MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-04 for HYDRO LEMAITRE VALVULOTOME 1009-00J manufactured by Lemaitre Vascular, Inc..
[83036797]
We have received and evaluated the complaint device and we were able to confirm the failure. The measured force to close the hoops was found to be with specification as well as the internal diameter of the sheath. When we measured the stiffness of the sheath, we found it be lower than normal. At this time, we are inconclusive about the root cause of the defect. 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. The 100 units of plastic assembly with silicone coating were all from a single lot that were used in manufacturing this lot only. Also, the sheaths used in manufacturing this lot were also used in 6 other lots. We have sold all of these valvulotomes. We have not confirmed any other complaints from other users related to similar incident from any of these lots. Our lot history records review did not reveal any discrepancies related to the complaint event either in the manufacturing or packaging processes. Hence, we believe that the incident is isolated only to this unit. The device was not used for the operation. The operation was completely successfully using the hospital stock ( catalog no. 1009-00/ lot no. 1195v ).
Patient Sequence No: 1, Text Type: N, H10
[83036798]
During pre-use check, the centering hoops were unable to open. The device was not used for operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00045 |
| MDR Report Key | 6769168 |
| Date Received | 2017-08-04 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-07-05 |
| Date Mfgr Received | 2017-07-05 |
| Device Manufacturer Date | 2017-02-22 |
| Date Added to Maude | 2017-08-04 |
| 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 | 2017-08-04 |
| Returned To Mfg | 2017-07-25 |
| Catalog Number | 1009-00J |
| 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 | 2017-08-04 |