MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-22 for PROCOL BIOLOGIC VASCULAR GRAFT, 6MM X 40 CM HJL016-40-N manufactured by Lemaitre Vascular, Inc..
[55720195]
The device was received for evaluation but since it had been prepped for use and exposed to blood/preservatives we were unable to reach any conclusions from our investigation. The device history record for this lot was reviewed. The lot passed all inspection criteria including: visual inspection, external diameter, and leak testing at simulated physiological pressure. This is a bioprosthetic device and variation along the graft is normal. Our ifu does state that a "small amount of oozing is acceptable". At this time we are unable to determine the cause of the incident but believe it was an isolated event.
Patient Sequence No: 1, Text Type: N, H10
[55720196]
During implantation of the graft, the surgeon pressurized it and noticed that a one inch section near the end appeared thin, lighter in color and started to slightly leak. The doctor removed the graft and used a different graft in stock without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2016-00021 |
| MDR Report Key | 5970207 |
| Date Received | 2016-09-22 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2016-08-24 |
| Device Manufacturer Date | 2015-07-24 |
| Date Added to Maude | 2016-09-22 |
| 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 | HANCOCK JAFFE LABS |
| Manufacturer Street | 70 DOPPLER |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROCOL BIOLOGIC VASCULAR GRAFT, 6MM X 40 CM |
| Generic Name | TISSUE GRAFT |
| Product Code | LXA |
| Date Received | 2016-09-22 |
| Returned To Mfg | 2016-08-28 |
| Model Number | HJL016-40-N |
| Device Expiration Date | 2019-12-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2016-09-22 |