MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-07 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202166168P0 manufactured by Intervascular Sas.
[129618902]
Device is not accessible for testing as it remained implanted in the 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 using a backlit table to reveal the presence of any holes in the textile structure. Moreover, the review of the water permeability testing records of a product coated on the same day as the complaint device indicated values well within product specifications. One retention sample from same product family, same lot and coated on the same day and under the same conditions as the involved device was visually inspected by a qc operator under real working conditions. No anomaly was found. This retention sample also underwent water permeability testing. The test result indicated a value well within product specifications (< 5 ml/cm? /min). The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number. No conclusion can be drawn since the product remained implanted. However, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
Patient Sequence No: 1, Text Type: N, H10
[129618903]
During surgery, a hole was identified at the crotch of the bifurcated graft. The surgeon sewed the graft hole in order to stop the bleeding. Patient was endangered but not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2018-00028 |
| MDR Report Key | 8142266 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-07 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-12-18 |
| Device Manufacturer Date | 2017-12-20 |
| Date Added to Maude | 2018-12-07 |
| 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 | 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 PLATINUM WOVEN DOUBLE VELOUR |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2018-12-07 |
| Model Number | M00202166168P0 |
| Catalog Number | M00202166168P0 |
| Lot Number | 17M20 |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2018-12-07 |