MAUDE Adverse Event Report: HEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175726AP0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of historical data indicated that no other similar complaints was reported for the same sterilization lot.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.The involved product was returned to intervascular and was visually inspected by our quality assurance (qa) supervisor.Results are as follows: "the discrepancy is confirmed, the graft presents yellow stains.¿ ¿these stains are similar to excesses of collagen which are routinely accepted according to acceptance criteria defined in [the internal list of standards for acceptation and rejection at qc step].This defect is a cosmetic defect.We have reviewed the graft with [a lead op ], we confirm that in its state the product should have been declared non-compliant, the non-compliance of the prosthesis of the complaint comes from the fact that there are several excesses." the outcome of the investigation would tend to indicate that the issue is related to a presence of collagen excesses which should have been rejected during the 100% visual inspection.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
Event or Problem Description
When the customer opened the package, they found some yellow blots on the surface of the graft.(b)(4).

• Brand Name: HEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• MDR Report Key: 9578287
• Report Number: 1640201-2020-00001
• Device Sequence Number: 2490434
• Product Code: MAL
• UDI-Device Identifier: 00384401018711
• UDI-Public: 00384401018711
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: M00202175726AP0
• Device Catalogue Number: M00202175726AP0
• Device Lot Number: 19D17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1