MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR; VASCULAR POLYESTER GRAFT

Model Number	M002020852010
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the product is available for investigation, it should be returned to intervascular for examination.A review of the complaint device history records is ongoing, results are pending.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
The hospital reported that during preparation for a procedure, upon opening the graft, it appeared to be a brown spot on the graft.The graft was never implanted.A replacement device was used to complete the procedure.No physician associated.No patient involvement.The date of the event is unknown.
Additional Manufacturer Narrative
(3331/213) a review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.These tests include a 100% visual inspection of the graft.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
(10/180) the involved product was returned to intervascular and was inspected by our quality assurance (qa) manager.His observations are as follows: "the product has been cut in half.Each of the 2 pieces of the product presents a coloured spot: - bifurcated part: brown spot of undetermined origin ; - body part: grey spot of undetermined origin ; the product, as it was received, does not conform to the specification.However, it should be noted that given the size of the two spots, it seems difficult that this type of defect could not have been detected by the quality control (qc) technician during the qc process with a backlit table and a magnifying glass lamp." (4315) the cause of the event remains unknown since the graft has been manipulated by the user and since both stains are near the cutting location.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.

• Brand Name: HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8510183
• Report Number: 1640201-2019-00024
• Device Sequence Number: 1524957
• Product Code: MAL
• UDI-Device Identifier: 00384401017776
• UDI-Public: 00384401017776
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2019

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: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: M002020852010
• Device Catalogue Number: M002020852010
• Device Lot Number: 17K11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/24/2019; 06/28/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/24/2019; 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1