MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN; VASCULAR POLYESTER GRAFT

Model Number	IGW0030-15
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the complaint device history records, indicated that the graft was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests.No anomaly was found.These tests include a 100% visual inspection of the graft.The investigation is still ongoing, the involved graft was returned for evaluation.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
The hospital reported that before using, while opening the package, the graft was found damaged at one end.A new graft was used for the procedure.
Additional Manufacturer Narrative
((b)(4)) the product was received without any packaging component.The visual inspection of the product performed by the quality assurance supervisor indicated that the device presents a cutting defect in one end.Therefore, the product as it was received, does not conform to the specification.A non conforming report has been initiated in order to investigate the event root cause and take corrective actions, if appropriate.Upon investigation, it appears that the cutting may not have been made during a manufacturing step.Therefore, the issue is highly probably due to a use error.

• Brand Name: INTERGARD WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6787650
• Report Number: 1640201-2017-00030
• Device Sequence Number: 16173405
• Product Code: DSY
• UDI-Device Identifier: 00384401000259
• UDI-Public: 00384401000259
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2017

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: 11/30/2020
• Device Model Number: IGW0030-15
• Device Catalogue Number: IGW0030-15
• Device Lot Number: 15M17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1