MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-21 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[68275809]
We have not yet received the complaint device for evaluation since the device is still at the transit. Hence, we cannot conclusively determine the root cause of the issue. There was no injury to the patient as the result of this incident. 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. While we are inconclusive regarding the root cause, this lot is part of an ongoing recall for issues with a similar description. We have informed the hospital regarding the recall on 02/09/2017. We will provide a follow-up report once we perform our investigation and determine the root cause. Device still in transit.
Patient Sequence No: 1, Text Type: N, H10
[68275810]
During valvulotomy, after the first usage, the blades did not close anymore.
Patient Sequence No: 1, Text Type: D, B5
[71766145]
This is a follow-up report with reference to mfr report number 1220948-2017-0014 that was submitted on february 21, 2017. We did not have the complaint device when the initial report was submitted. We have received and evaluated the complaint device. We have confirmed the reported failure. We found tails of the centering hoop was sticking out of the sheath preventing closure of the device. We are aware of this issue and have an ongoing recall that includes this lot number. We had notified this hospital to return all affected devices on 02/09/2017. 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. However, we did initiate a corrective action to investigate and resolve complaints related to similar issues. We have implemented a design change to our device that includes a heat shrink covering of the blades. We believe this change, along with some other process improvements, will eliminate the issue that our customer experienced.
Patient Sequence No: 1, Text Type: N, H10
[71766146]
During valvulotomy, after the first usage, the blades did not close anymore.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00014 |
| MDR Report Key | 6347639 |
| Date Received | 2017-02-21 |
| Date of Report | 2017-03-16 |
| Date of Event | 2017-01-03 |
| Date Mfgr Received | 2017-01-16 |
| Device Manufacturer Date | 2016-07-28 |
| Date Added to Maude | 2017-02-21 |
| 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 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 | 3 |
| Brand Name | HYDRO LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2017-02-21 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1101V |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON 01803 US 01803 |
| Brand Name | HYDRO LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2017-02-21 |
| Returned To Mfg | 2017-01-23 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1101V |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-21 |