MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-09 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[77639154]
We have received the device for evaluation. When we evaluated this device, we did not find any issue that might have contributed to the failure. All of the blades were able to insert into the retainer when the device was opened and closed multiple times. All of the centering hoops were also able to insert into the sheath. We did not experience any resistance when closing the hoops into the sheath. However, we observed that the tip of the sheath was ripped which was as a result of the hoops not closing completely when entering into the sheath. However, all of the hoops were able to close completely into the sheath when the green handle was pulled all the way. We could not conclusively determine the root cause of the defect since we could not replicate the defect during our evaluation. During our follow-up, we learned that the centering hoops were partially closed when the physician withdrew the device out of the patient's vein with a blade not inserting all the way into the retainer. As, a result, it cut the distal end (1-2 cm)of the vein. The complaint device was tested before the procedure by the surgeon and was found to be working as expected. It is possible that the root cause of this defect is due to excessive force used by the physician when he was trying to close the blades all the way into the retainer. The physician then cut off the cut section of the vein and completed the anastomosis using the remaining portion of the vein. The operation completed successfully without any complication. Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident. Further, we have not received any other complaints of similar nature for devices from this lot.
Patient Sequence No: 1, Text Type: N, H10
[77639155]
During non-reverse bypass, the physician felt a resistance when closing the blades into the retainer. As a result, it cut distal 1-2 cm of the vein since the centering hoops were removed in the partially open position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00039 |
| MDR Report Key | 6630871 |
| Date Received | 2017-06-09 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2017-02-28 |
| Date Added to Maude | 2017-06-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYDRO LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2017-06-09 |
| Returned To Mfg | 2017-06-02 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1188V |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-06-09 |