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

Model Number	M00202175208P0
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records review concluded that there was no nonconformance / 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.A visual inspection of the complaint device was performed by our quality assurance (qa) supervisor.A deformation at one end of the graft was confirmed and the cutting was not regular.It was concluded that these defects were probably due to a human error during manufacturing (trimming process).The product, as it is, is not conform.The conducted investigation indicates that the device was defective.The most probable cause is a trimming process failure leading to a non conforming product.An internal 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 open a package with a graft, they found that the shape of one end of the graft is not circular, but pressed.The surgical procedure was completed with another graft of the same model.There was no patient effect reported.It was later confirmed by the customer that the product was positioned correctly in the packaging.

• Brand Name: HEMASHIELD PLATINUM WOVEN
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• MDR Report Key: 12107939
• Report Number: 1640201-2021-00021
• Device Sequence Number: 4580898
• Product Code: MAL
• UDI-Device Identifier: 00384401018148
• UDI-Public: (01)00384401018148
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/02/2021

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: 08/31/2025
• Device Model Number: M00202175208P0
• Device Catalogue Number: M00202175208P0
• Device Lot Number: 20J02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/02/2021
• Patient Sequence Number: 1