MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-23 for LINVATEC HIGH FLOW SHEATH 5.9 MM 281332 manufactured by Depuy Mitek Llc Us.
[114720249]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The complaint device was received and inspected. Visual observation reveals that the handle and spring are missing. The threads on the valves are worn and cannot be connected into the sheath. The sheath itself looks worn with nicks and marks and the distal edge slightly bent consistent with it being used. Repeated use and sterilization cycles can lead to this type of failure and therefore can be attributed to field wear. Other than this possibility, we cannot discern a root cause for this failure. Furthermore, a lot review was not available in spite of three requests sent out to the supplier. Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution. At this point in time, no corrective action is required and no further action is warranted. However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Patient Sequence No: 1, Text Type: N, H10
[114720270]
It was reported that the biomed from the facility reported the handle in their 5. 9mm linvatec high flow sheath broke off and the spring fell out prior to an unknown procedure on an unknown date. The surgeon used another sheath to complete the procedure with no patient consequences or delays. The device is coming back for evaluation. No further details were available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-52033 |
| MDR Report Key | 7710692 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-23 |
| Date of Report | 2014-06-04 |
| Date Mfgr Received | 2018-07-24 |
| Date Added to Maude | 2018-07-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MRS. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | MITEK RAYNHAM MFG |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINVATEC HIGH FLOW SHEATH 5.9 MM |
| Generic Name | RIGID ENDOSCOPE SHEATH |
| Product Code | HRX |
| Date Received | 2018-07-23 |
| Returned To Mfg | 2014-06-16 |
| Catalog Number | 281332 |
| Lot Number | 52517026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Brand Name | LINVATEC HIGH FLOW SHEATH 5.9 MM |
| Generic Name | RIGID ENDOSCOPE SHEATH |
| Product Code | HNX |
| Date Received | 2018-07-23 |
| Returned To Mfg | 2014-06-16 |
| Catalog Number | 281332 |
| Lot Number | 52517026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-23 |