MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-03-01 for HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR M002020851260 manufactured by Intervascular Sas.
[139341301]
Device is not accessible for testing as it remained implanted in patient. 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. These tests include a 100% visual inspection of the graft. Specifically, the review of the collagen coating records evidenced no anomaly. No retention sample from same lot and coated on the same day and under the same conditions as the involved device is available for inspection. The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number. 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
[139341302]
Two vascular grafts were sutured together and were used on the same patient (see manufacturer report 1640201-2019-00013 for the other involved device). When suturing the grafts to be implanted, it was noticed that the collagen coating was crumbling like bread crumbs. The surgeon wet the grafts with sterile saline and no more crumbling was noticed. The grafts were implanted in the abdominal area with no other signs of issues or complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2019-00012 |
| MDR Report Key | 8382221 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-01 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2017-08-30 |
| Date Added to Maude | 2019-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LAURE FRAYSSE |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal | 13705 |
| Manufacturer G1 | INTERVASCULAR SAS |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 13705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2019-03-01 |
| Model Number | M002020851260 |
| Catalog Number | M002020851260 |
| Lot Number | 17H30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVASCULAR SAS |
| Manufacturer Address | Z.I. ATHELIA I LA CIOTAT CEDEX, 13705 FR 13705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-01 |