Precautions; Adverse Events And Troubleshooting Information; During Use Of The Puncture Set; During Use Of The Voice Prosthesis - Atos Medical Provox Vega Instrucciones De Uso

• DO choose laryngectomy tubes or stoma buttons, if used, with a suitable shape that do
not exert pressure on the prosthesis during use, or catch onto the tracheal fl ange of the
prosthesis during insertion and removal of the tube or button.

1.5 PRECAUTIONS

Always assess the suitability of the tissue in the area of the TE puncture. In cases with
lacking suitability, e.g. due to excessive scar tissue or radiation fi brosis, proceed with great
care and abort the procedure if dilatation of the TE puncture requires too much force.
• DO carefully assess patients with bleeding disorders or patients undergoing
anticoagulant treatment for the risk of bleeding or hemorrhage, prior to secondary
puncture and prosthesis placement.
• DO always use aseptic technique when handling the Puncture Set in order to reduce
risk for infection.
• DO remove the Pharynx Protector before initiating dilatation. The voice prosthesis
may get stuck inside the Pharynx Protector if attempting to complete the procedure
without removing the Pharynx Protector.
• DO ensure that the Guidewire is adequately threaded and locked in position in the
Wirelock. If proper locking is not achieved, the Guidewire may come loose from the
Wirelock, causing failure to complete procedure.
• DO always proceed slowly and without using excessive force during dilatation and
placement of the prosthesis. Tissue damage may otherwise occur.
• DO support the TE tissue during dilatation. Otherwise, rupture may occur. In case
of a rupture of the TE tissue the TE puncture procedure should be abandoned and
the rupture should be sutured immediately. TE puncture should only be repeated after
proper healing of the tissues.
• DO NOT reload after the safety strap of the prosthesis has been cut off, as the safety
mechanism in that case has been compromised, with risk for dislocation of the voice
prosthesis during the procedure.

1.6 Adverse events and troubleshooting information

1.6.1 During use of the Puncture Set

(Sub-) mucosal injury
During puncture, the Puncture Needle or the Guidewire could cause a (sub) mucosal
injury if the Pharynx Protector is not located in its correct position, or if the puncture is
made incorrectly. In case of suspicion of (sub)mucosal damage, it is recommended that
the patient receives a prophylactic course of postoperative antibiotics and is fed through
a nasogastric tube or similar to allow healing.
Re-puncture
If the Pharynx Protector is not positioned appropriately when puncturing, or if, for any
other reasons, there is need for re-puncture, the tissue should be assessed for possible
sub-mucosal injury and the puncture procedure repeated with the Pharynx Protector
positioned correctly.
Forgot to remove the Pharynx Protector
If the Puncture Dilator is connected to the Guidewire prior to removal of the Pharynx
Protector, the procedure cannot be completed. If this occurs, detach the Puncture Dilator
from the Guidewire and remove the Pharynx Protector. Also see Reloading below.
Reloading
In some cases, reloading of the Puncture Dilator may be necessary; e.g., if the voice
prosthesis is pulled completely through the puncture during prosthesis placement. The
reloading procedure is described in section 2.2.3 and illustrated in Fig. 4.

1.6.2 During use of the voice prosthesis

Dislodgement of the voice prosthesis– Dislodgement can be caused by infection
and/or edema of the TE-puncture, granulation around the puncture or hypertrophic
scarring around the puncture. Dislodgement might lead to aspiration or ingestion of the
prosthesis. See below.
Aspiration of the prosthesis – Accidental aspiration of the voice prosthesis or other
components of the voice rehabilitation system may occur. As with any other foreign
body, complications from aspiration of a component may cause obstruction or infection.
Immediate symptoms may include coughing, wheezing or other abnormal breathing sounds,
dyspnea, and respiratory arrest, partial or inadequate air exchange and/or asymmetrical
chest movement with respiration. Complications may include pneumonia, atelectasis,
bronchitis, lung abscess, bronchopulmonary fi stula and asthma.
If the patient can breathe, coughing may remove the foreign body. Partial airway
obstruction or complete airway obstruction requires immediate intervention for removal
of the object. If aspiration of the device is suspected, a CT scan of the lungs should be
performed to confi rm aspiration and locate the device. If the CT scan confi rms aspiration of
the device, the device may be retrieved endoscopically using a non-toothed grasping forceps.
The silicone housing of the Vega voice prosthesis can also be located endoscopically. On
a CT scan and during endoscopy, the device may appear as a oval shape with an opening
in the middle with an outer diameter of about 10-17 mm (the fl anges of the device), or as
a cuffl ink shape with a shaft length of 8, 10, 12.5 or 15 mm, depending on the size of the
device. During endoscopy, refl ections from the light source on the clear silicone rubber
may be seen. Also, in prostheses that have been in situ for some time, white or yellow
appearing Candida deposits may be visible on the device.
Ingestion of the prosthesis – Accidental ingestion of the voice prosthesis, or other
components of the voice rehabilitation system, may occur. As with any other foreign
body, the symptoms caused by ingestion of the prosthesis or a component of the voice
rehabilitation system depends largely on size, location, degree of obstruction (if any)
and the length of time it has been present. Ingested components that have remained in
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