MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-27 for PROCOL BIOLOGIC VASCULAR GRAFT HJL016-40-N manufactured by Lemaitre Vascular, Inc..
[63625728]
We have received and investigated the complaint device for reported incident. We have confirmed the defect. We found that the device was oozing with some permeability from one point nearer to one end from the graft. This is a bioprosthetic device and variation along the graft is normal. Our ifu does state that a "small amount of oozing is acceptable". All grafts are subjected for leak testing prior to acceptance into inventory.
Patient Sequence No: 1, Text Type: N, H10
[63625729]
When the surgical tech was flushing the graft, he noticed the graft was leaking from the midpoint of the graft. So, he clamped the distal end and lightly flushed the graft, which then showed diffuse weeping from multiple areas. No obvious defect was noted. The graft was then discarded and then another graft was used. The graft was not used in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2015-00026 |
| MDR Report Key | 6207935 |
| Date Received | 2016-12-27 |
| Date of Report | 2016-12-27 |
| Date of Event | 2016-11-14 |
| Date Mfgr Received | 2016-11-28 |
| Date Added to Maude | 2016-12-27 |
| 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 |
| Generic Name | VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2016-12-27 |
| Returned To Mfg | 2016-12-02 |
| Model Number | HJL016-40-N |
| Device Expiration Date | 2019-11-25 |
| 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 | 1. Required No Informationntervention | 2016-12-27 |