MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD KNITTED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	IGK0007-70
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved product was returned to intervascular and will be inspected by our quality assurance (qa) manager for an evaluation.The review of post-marketing historical data indicated that one other similar complaint was reported for the same sterilization lot number, but not the same product model.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, including a 100% visual inspection.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
According to the client: "following the intervention of dr.(b)(6), the diameter contained in the intergard diam 7mm length 70 cm ref igk0007-70 was not 7mm", so he had to use another prosthesis of the bbraun range in diameter 8 mm.
Additional Manufacturer Narrative
(10/213) the involved product was returned to intervascular and was inspected by the quality assurance (qa) manager for evaluation.His observations are as follows: "the graft arrived without packaging and labelling.It was packaged in a biohazard packaging.The graft was measured by n.E (an experienced technician) according to established procedure pqsd2633/16 (with a measuring cone set mes 12-078 (validity date : 18/05/2021)) and versus specification pqsd0322/10.The graft is in compliance with specification (7.5mm measure vs a specification of 7,0 +/- 0.5mm).(67) the conducted investigation suggests that the product was not defective.
Event or Problem Description
According to the client: "following the intervention of dr.Brami, the diameter contained in the intergard diam 7mm length 70 cm ref igk0007-70 was not 7mm", so he had to use another prosthesis of the bbraun range in diameter 8 mm.

• Brand Name: INTERGARD KNITTED
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9129521
• Report Number: 1640201-2019-00051
• Device Sequence Number: 2478042
• Product Code: DSY
• UDI-Device Identifier: 00384401000860
• UDI-Public: 00384401000860
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964625
• 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): 10/24/2019

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: 10/31/2023
• Device Model Number: IGK0007-70
• Device Catalogue Number: IGK0007-70
• Device Lot Number: 18L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1