MAUDE Adverse Event Report: INTERVASCULAR SAS HEMACAROTID PATCH ULTRATHIN; VASCULAR POLYESTER GRAFT

Model Number	HEK08/75 CPUT (1)
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaint device history records, indicated that the patch was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests.These tests include a 100% visual inspection of the patch.It was reported that the product is available for investigation, it should be returned to the manufacturer for evaluation.The investigation is still ongoing.A follow up report will be sent upon complementation of the investigation.
Event or Problem Description
It was reported that the item has arrived moist in the package.
Additional Manufacturer Narrative
A visual inspection of the returned product was performed by the quality assurance supervisor.The product was found in its original packaging, with its transparent tamper-evident label removed.The box was teared and wet.The external and internal tyvek were also wet, the double sealing was undamaged.The device as it was received does not conform to the specifications because of its damaged and soiled packaging.The conducted investigation and testing performed would tend to indicate that the product was not defective.However, the device as it was received does not conform to the specifications because of its damaged and soiled packaging.The most probable cause of this event is that the damage occurred during the shipment.

• Brand Name: HEMACAROTID PATCH ULTRATHIN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6685496
• Report Number: 1640201-2017-00022
• Device Sequence Number: 18872682
• Product Code: DSY
• UDI-Device Identifier: 00384401001478
• UDI-Public: 00384401001478
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K983819
• 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): 07/05/2017

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: 02/28/2022
• Device Model Number: HEK08/75 CPUT (1)
• Device Catalogue Number: HEK08/75 CPUT (1)
• Device Lot Number: 17C16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1