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
We don't know if the delay of surgery had any impact on the patient stability.It was reported that the product is available for investigation, it should be returned to intervascular for examination.(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, including a 100% visual inspection.Specifically, no anomaly was evidenced in the textile records.The review of post-marketing historical data indicated that no other similar 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
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
(10/213) the involved device was returned to intervascular for examination and was inspected by our quality assurance (qa) supervisor for dimension evaluation.His observations are as follows: "the prosthesis arrived in a biohazard package in the original box with the instructions and part of the patient set, and with the graft sizer with its instructions.There is no shell or lid.The product has been cut, it measures 16.5cm instead of 30cm the product is frayed at the cutting area.As the product has been cut, it is not possible to rule on the conformity of the product.However it seems that the tool used for cutting is a probable cause of fraying, as some wires have not even been cut." "no defect regarding the product during the inspection was identified." (67) the conducted investigation suggests that the product was not defective at the time of manufacturing.(61) 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.
Event or Problem Description
The graft was verified before use and it was found to be unraveling.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: 9087559
• Report Number: 1640201-2019-00047
• Device Sequence Number: 2401902
• Product Code: MAL
• UDI-Device Identifier: 00384401018254
• UDI-Public: 00384401018254
• 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): 11/07/2019

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
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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