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

Model Number	M00202175132P0
Medical Device Problem Codes	Material Frayed (1262); Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The use of the device do not follow manufacturer recommendation because it was cut with scissors.According to product instructions for use: "woven grafts should be cut with a low temperature, disposable cautery (e.G., ¿ 900°f/¿ 500°c) to prevent raveling" the device history records review concluded that there is no non-conformance / planned deviation in relation with the event reported.(the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.The involved device was received.The investigation is ongoing.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
The vascular graft showed a strong fraying after cutting with potts scissor.The graft was then implanted after cleaning of the cut edge to remove particles.The surgery was just a few minutes delayed in relation with the cleaning of the cut edge.No harm to patient was reported until today.The non-implanted part is available for inspection.The customer always cuts prosthesis with scissors.The customer has been switched from competitors to getinge hemashield.
Additional Manufacturer Narrative
(4112/213) the case has been reviewed by our corporate medical officer whose assessment is below: "i reviewed the complaint attached and the picture provided regarding the use of a hemashield woven double velour vascular graft.It is mentioned that the user has recently adopted the hemashield graft and that he is routinely using scissors to cut the graft to size.I also reviewed the picture provided regarding the fraying that has been observed.It is clear that the fraying is due to the use of scissors instead of a low temperature disposable cautery like indicated in our instructions for use to avoid this very outcome.Nothing seen in the pictures is surprising or not expected for this product when a scissor is used.The use of a disposable (low temperature) cautery eliminates the fraying.The customer should be retrained and instructed to use exclusively this tool with woven products." unintended use error caused or contributed to event.Indeed, we learned during the investigation that: "the vascular graft showed a strong fraying after cutting with potts 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: "woven grafts should be cut with a low temperature, disposable cautery (e.G., ¿ 900°f/¿ 500°c) to prevent raveling.".In accordance with our complaint handling work instruction, customer will be specifically informed of this recommendation via the complaint response sent to the customer in order to prevent recurrence of the use error.
Event or Problem Description
See mfr report 1640201-2020-00018.Complaint (b)(4).
Event or Problem Description
See initial mfr report # 1640201-2020-00018.Complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: fragments of the involved product were returned to intervascular and were inspected by the quality assurance manager for an evaluation of the damage extent.His observations are as follows: "i have inspected the product fragments returned.The graft was cut with scissors, which has led to this frayed appearance.The non-cut extremity has no defect.Based on the inspection, the graft does not present any nonconformity." the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Corrected data: in h6, device code 1506 (product quality issue) is replaced by 1262 (material frayed) in order to better represent what the customer observed during the event and the inspection conclusion.

• 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: 10302551
• Report Number: 1640201-2020-00018
• Device Sequence Number: 11476513
• Product Code: MAL
• UDI-Device Identifier: 00384401018094
• UDI-Public: 00384401018094
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2020

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: 04/30/2025
• Device Model Number: M00202175132P0
• Device Catalogue Number: M00202175132P0
• Device Lot Number: 20E20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 07/27/2020; 08/12/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/04/2020; 09/02/2020
• 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