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

Model Number	M00202175430P0
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trackwise # (b)(4).If new information was to become available, the file will be re-opened and updated.A follow up mdr will be sent.
Event or Problem Description
The graft was verified before use and it was found to be unravelling.Customer used a different unit to complete the procedure.Surgery was prolonged.
Additional Manufacturer Narrative
(b)(4).If new information was to become available, the file will be re-opened and updated.A follow up mdr will be sent.
Event or Problem Description
The graft was verified before use and it was found to be unravelling.Customer used a different unit to complete the procedure.Surgery was prolonged.

• Brand Name: HEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9211520
• Report Number: 2242352-2019-01170
• Device Sequence Number: 18944601
• Product Code: MAL
• UDI-Device Identifier: 00384401018254
• UDI-Public: 00384401018254
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019
• Report Date (Section F): 11/08/2019

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: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: M00202175430P0
• Device Catalogue Number: M00202175430P0
• Device Lot Number: 19D24
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 11/08/2019