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

Model Number	M00202175830P0
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.The involved product was returned to intervascular.A visual inspection by our quality assurance (qa) supervisor is anticipated but not yet performed.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
(b)(4): the product was opened to use during surgery and hair was found in the product.The surgery was finished with a new product of the same model that he had.The product can be returned.
Additional Manufacturer Narrative
(10/170) - (10/646) the involved product was returned to intervascular and was inspected by the quality assurance supervisor for evaluation.Below are the main elements of the inspection results: - returned product was no more in a sealed package.Product was located in the outer blister pack, but the inner blister pack was missing.- a black fiber, which may look like a hair, was found in the outer blister, it was not on the prosthesis.- the fiber could come from textile or be a foreign matter.- according to our current list of standards for acceptation and rejection, the product is non-compliant.- since the product has been manipulated by the user, it is not possible to confirm whether the fiber was generated during our process or not.In summary, the product does not comply with the specification due to presence of a fiber, which could come from textile or be of foreign origin.Due to manipulation by user, the cause cannot be traced with certainty to manufacturing.It is why two codes of results are used (one for manufacturing process problem identified, the other for environment of use: device performance could have been affected by the environment in which it was used).(4315) the investigation findings do not lead to a clear conclusion about the cause of the reported event.However, it is confirmed that the product does not comply with the specification.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
Event or Problem Description
Complaint #(b)(4).

• Brand Name: HEMASHIELD PLATINIUM WOWEN 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: 9938750
• Report Number: 1640201-2020-00008
• Device Sequence Number: 19457123
• Product Code: MAL
• UDI-Device Identifier: 00384401018582
• UDI-Public: 00384401018582
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 11/30/2024
• Device Model Number: M00202175830P0
• Device Catalogue Number: M00202175830P0
• Device Lot Number: 19M25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1