MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-12 for PROVOX ACTIVALVE 7161 manufactured by Atos Medical Ab.
[57576556]
Investigation: ring, flap and housing are separated from each other, safety strap is intact. The loading tube has white stress marks. The blue ring has a white stress marks and a crack located close to the hinge. The housing is ruptured approx. 3 mm close to the esophagus flange, where it meets the waist of the housing. These observations strongly indicate that abnormal stress has been applied to material and components. The most likely scenario is that the esophagus flange was wrongly (backwards) folded while traveling through the loading tube. Discussion: during insertion the loading tube is placed in the puncture. If the ring is separated from the prostheses during insertion, the most likely scenario is that the ring would end up in the esophagus, not the trachea. Conclusion/ action: based on the description in the complaint report vs. Discussion and the observations of damage to the components, this complaint is judged to not be a result of a faulty product. The clinician should be instructed to follow the ifu to secure a proper handling when inserting the activalve. The clinician may need additional education.
Patient Sequence No: 1, Text Type: N, H10
[57576557]
During insertion of the voice prosthesis, the inserter pin broke through the prosthesis and the blue ring of the activalve came loose and detached from the silicon corpus of the valve. All parts could be retrieved from the trachea with suction. The patient was not affected by the event and has now a replacement valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00008 |
| MDR Report Key | 6019698 |
| Date Received | 2016-10-12 |
| Date of Report | 2016-08-12 |
| Date of Event | 2016-07-26 |
| Date Mfgr Received | 2016-07-26 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2016-10-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ELIN ALGOTSSON |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-24222 |
| Manufacturer Phone | 641519800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | PO BOX 183 KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-242 22 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROVOX ACTIVALVE |
| Generic Name | LARYNGEAL VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-10-12 |
| Returned To Mfg | 2016-07-29 |
| Catalog Number | 7161 |
| Lot Number | 1411137 |
| Device Expiration Date | 2017-10-31 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 KRAFTGATAN 8 HORBY, SE-242 22 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-12 |