MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR; VASCULAR POLYESTER GRAFT

Model Number	M00202175208P0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not accessible for testing.A review of the complaint device history records is ongoing; results are pending.Two unopened devices from same lot will be returned from the customer.They will undergo water permeability testing.The review of post-marketing historical data indicated that no other 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.
Event or Problem Description
Following a return of unopened original packaging grafts for credit, it was reported that surgeons do not want to use this graft type anymore since the involved graft leaked/oozed blood when implanted.There was no injury to the patient but event details are unavailable (date, description, incident handling).
Additional Manufacturer Narrative
(3331/213) 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 records.Moreover, the review of the water permeability testing records of a product of the same lot and coated on the same day as the complaint device indicated values well within product specifications (< 5 ml/cm²/min).(4101/4103/213) seven unopened original packaging grafts were returned by the customer to intervascular and were visually inspected by our quality assurance (qa) manager.No anomaly was found, all seven products comply with their specifications.Among the seven products returned, two belong to the same lot and were coated on the same day and under the same conditions as the involved device.They underwent water permeability testing.The test results indicated values well within product specifications (< 5 ml/cm²/min).(67) no conclusion can be drawn since the product is not available for evaluation.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.

• Brand Name: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8382786
• Report Number: 1640201-2019-00016
• Device Sequence Number: 1976012
• Product Code: MAL
• UDI-Device Identifier: 00384401018148
• UDI-Public: 00384401018148
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 05/31/2023
• Device Model Number: M00202175208P0
• Device Catalogue Number: M00202175208P0
• Device Lot Number: 18F06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1