MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-26 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[76247003]
We have received the complaint device for evaluation. We found that the tail of one of the centering hoop was caught on the distal end of the sheath. The device was manufactured with a heat shrink to prevent this issue from occurring. When we cut about 10 cm of the distal end of the sheath, we found the heat shrink has slided 3 cm below the tails of the centering hoop. This is the first complaint we have received related to this failure mode. We tried to replicate the defect at different manufacturing settings. We were able to replicate the defect when the heat shrink was already punctured prior to silicone dipping. This will allow the silicone to penetrate into the heat shrink and lubricates the heat shrink. As a result, they can slip off from their location. 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. Therefore, we believe that it was an isolated incident. There was no injury to the patient since device was not used for the procedure.
Patient Sequence No: 1, Text Type: N, H10
[76247004]
During pre-use check, the physician tried to close the centering hoops into the sheath. However, he felt a resistance while doing so. So, he used the hospital stock of hydro to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00036 |
| MDR Report Key | 6595248 |
| Date Received | 2017-05-26 |
| Date of Report | 2017-05-26 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2016-12-14 |
| Date Added to Maude | 2017-05-26 |
| 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 | 2017-05-26 |
| Returned To Mfg | 2017-05-04 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1173V |
| 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 | 2017-05-26 |