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

Model Number	M00202175416P0
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of historical data indicated that no other complaint 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.It was reported that the product is available for investigation, it should be returned to intervascular for examination.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.The device was not returned yet.
Event or Problem Description
Surgeon cut the graft with scissors for use on the patient, but a lot of seams appeared on the cut surface of the graft.User replaced the product with hgk0014-40 to complete the operation.No patient info from this hospital.
Event or Problem Description
See initial mfr report # (b)(4).Complaint # (b)(4).Additional information: "the surgeon cut the graft using a general surgical scissor (metzenbaum scissor).".
Additional Manufacturer Narrative
(10/213) the involved product was returned to intervascular and was visually inspected by our quality assurance (qa) supervisor.The conclusions are: "the discrepancy is confirmed, the graft is frayed ¿ ¿except the part cut by the surgeon, the rest of the graft is compliant".¿it is not possible to conclude that the product was not defective at the time of manufacturing because the returned product examined is defective now, however it is unlikely that the graft was like this at factory leave¿.(67) the conducted investigation suggests that the product was not defective at the time of manufacturing.(61) unintended use error caused or contributed to event.Indeed, during the investigation, we were informed that "the surgeon cut the graft using a general surgical scissor (metzenbaum scissor)".However, due to their intrinsic weaving pattern, woven grafts are prone to fraying when cut with scissors.As indicated in the product instructions for use, a low-temperature disposable cautery should be used to minimize fraying when cutting this graft.

• Brand Name: HEMASHIELD PLATINUM - WOVEN DOUBLE VELOUR VASCULAR GRAFT
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9391872
• Report Number: 1640201-2019-00087
• Device Sequence Number: 11180391
• Product Code: MAL
• UDI-Device Identifier: 00384401018186
• UDI-Public: 00384401018186
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 04/30/2024
• Device Model Number: M00202175416P0
• Device Catalogue Number: M00202175416P0
• Device Lot Number: 19E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1