MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-28 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[96126205]
We have received and evaluated the complaint device. The device operated as expected and we could not replicate the defect as shown in the picture provided by our sales rep in (b)(4). All of the centering hoops were able to insert into the sheath and the blades entered and exited the retainer as expected. The gap between the end of the retainer and the tip of the sheath was higher than our specification by 1mm. However, all of the centering hoops were able to insert into the sheath. Even when we coiled the device and tried to replicate the device, the device operated as expected. We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue. All qc tests passed their requirements. Further, we have not received any other complaints of a similar nature for devices from this lot. Hence, we consider this to be an isolated incident. At this time, we are inconclusive about the root cause of the defect since we could not replicate the defect as shown in the picture. It is possible that the silicone coating that is used to lubricate the wire to reduce friction between the sheath and the wire was not coated properly. As a result, the friction prevented the centering hoops from closing completely into the sheath. It is also possible that the device was excessively coiled which could have let to this failure. Our ifu does warns the user not to open or close the device in a coiled configuration. Device was tested before use and was found to be operational. There was no injury to the patient as the result of this incident. The operation was completed successfully by using the same catheter.
Patient Sequence No: 1, Text Type: N, H10
[96126206]
After performing valvulotomy of great sephanous vein succesfully for in-situ bypass, the catheter was removed from the vessel. Physician noticed that the centering hoops of the catheter did not close completely into the sheath of the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00073 |
| MDR Report Key | 7152274 |
| Date Received | 2017-12-28 |
| Date of Report | 2017-12-28 |
| Date of Event | 2017-11-29 |
| Date Mfgr Received | 2017-12-02 |
| Device Manufacturer Date | 2015-12-02 |
| Date Added to Maude | 2017-12-28 |
| 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 | 2017-12-28 |
| Returned To Mfg | 2017-12-19 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1081V |
| 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 | 2017-12-28 |