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

Model Number	M00202175924P0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(3331/213) the device history records review concluded that there was no deviation identified related to the reported event.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22k05.(4102/3233) one retention sample from another sterilization lot number was selected based on the same textile fabric, and the same coating date and parameters as the involved device.A visual inspection of it will be performed.(11) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
It was initially reported to intervascular that when the surgeon opened the package, he noticed some dark spots on the surface of the graft.The surgeon didn't use the product, he used another graft instead to complete the operation.Additional information received from the initial reporter confirmed that the surgery was not delayed since the surgeon identified the issue just after he opened the package and no preliminary steps were performed on the graft.
Additional Manufacturer Narrative
(10/4248) the involved device was returned to intervascular.A visual inspection was performed by the quality assurance (qa) supervisor, who observed that the product has been handled by the customer.Indeed, the packaging was opened and some of its components were missing.The graft presented numerous black/brown spots on both the front and back surfaces.Moreover, the body of the graft shows lighter spots that could be related to collagen spots, but it is not certain due to the condition of the returned product.(4102/213) one retention sample from a different sterilization lot number was selected based on the same fabric type (woven) and the same coating date and parameters as the involved product.A visual inspection of the retention sample was performed by the qa supervisor, it is concluded that the retention sample is in compliance with the specifications.(19/4315) based on the investigation findings, no conclusion can be drawn on the exact origin of the reported stains.Following the involved product inspection, it was revealed that the product has been manipulated by the customer.Therefore, considering the general condition of the returned product, it is not possible to identify the origin of the stains reported in this complaint.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.
Event or Problem Description
Complaint #(b)(4).

• 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
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 17170027
• Report Number: 1640201-2023-00018
• Device Sequence Number: 20633237
• Product Code: MAL
• UDI-Device Identifier: 00384401018636
• UDI-Public: (01)00384401018636
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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 Model Number: M00202175924P0
• Device Catalogue Number: M00202175924P0
• Device Lot Number: 22K05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown