MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-04 for INTERGARD/HEMAGARD HEMAGARD KNITTED AXILLO RS HGKAX100808RS35/20 manufactured by Intervascular Sas.
[169025829]
Device is not accessible for testing as it remained implanted in the patient. The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number. A review of the complaint device history records indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests. Specifically, no anomaly was evidenced in the collagen coating and textile records. Moreover, the review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications (< 5 ml/cm? /min). The investigation is still ongoing. A follow-up report will be sent upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[169025830]
During an axillo bi-femoral procedure, the hemagard graft leaked for approximately 1. 5 cm at the end of one of the legs of the graft. The surgeon cut this section off and disposed of. The graft was used one day past its expiry. We later received additional information concerning the event handling: "when the surgeon unclamped and blood was free flowing the graft leaked at a small section at the end of one of the? Graft legs?. The surgeon had too re clamp, cut off the leaking section and disposed of it immediately. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242352-2019-01334 |
| MDR Report Key | 9409460 |
| Date Received | 2019-12-04 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-06-29 |
| Date Facility Aware | 2020-02-25 |
| Report Date | 2020-03-20 |
| Date Reported to FDA | 2020-03-20 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2019-12-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERGARD/HEMAGARD |
| Generic Name | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Product Code | DSY |
| Date Received | 2019-12-04 |
| Model Number | HEMAGARD KNITTED AXILLO RS |
| Catalog Number | HGKAX100808RS35/20 |
| Lot Number | 14G17 |
| Device Expiration Date | 2019-06-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVASCULAR SAS |
| Manufacturer Address | ZONE INDUSTRIELLE ATHELIA I LA CIOTAT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-04 |