MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for PROCOL BIOLOGIC VASCULAR GRAFT HJL016-40-N manufactured by Lemaitre Vascular, Inc..
[139855758]
We have not received the graft for evaluation. The device is currently on transit and is expected to arrive at the manufacturing site on the week of 03/25/2019. At this time, we could not conclusively determine the root cause of the defect. 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 a similar nature for devices from this lot. Therefore, we believe that it was an isolated incident. Surgeon observed the attribute on the graft through its glass package and the graft was not removed from its packaging.
Patient Sequence No: 1, Text Type: N, H10
[139855759]
Surgeon observed an aneurysm on the distal section of the graft. The attribute was visible through its glass package and the graft was not removed from its packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00028 |
| MDR Report Key | 8445484 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2016-07-12 |
| Date Added to Maude | 2019-03-22 |
| 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 |
| 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 | PROCOL BIOLOGIC VASCULAR GRAFT |
| Generic Name | VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2019-03-22 |
| Catalog Number | HJL016-40-N |
| Lot Number | 016-T2925-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-22 |