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.Please note that because we did not receive any ack3 for the previous initial mdr (mfr report # 1640201-2020-00008) made for this complaint, a second initial mdr is sent.
Event or Problem Description
Complaint #(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.
Event or Problem Description
See initial mfr reports # 1640201-2020-0008 and # 1640201-2020-00010 complaint # (b)(4).
Additional Manufacturer Narrative
Corrected data block h10: the initial mfr report # 1640201-2020-00008 in relation with the complaint (b)(4) was finally successfully received by fda on 8 april 2020, and the mfr report # 1640201-2020-00010 was also successfully received on 8 april 2020, therefore there are now two mfr reports in duplicate for the same complaint (b)(4).This follow up report # 1640201-2020-00010 is done to inform that the mfr report # 1640201-2020-00010 does not need to be considered anymore.Any follow up concerning the investigation for complaint (b)(4) will be communicated with reference to the mfr report # 1640201-2020-00008.We apologize for the inconvenience created by this duplication.

• 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: 9941478
• Report Number: 1640201-2020-00010
• Device Sequence Number: 16969977
• 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): 04/24/2020

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: 04/09/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1