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

Model Number	INTERGARD WOVEN GRAFT
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
((b)(4)) the product was returned for evaluation.A mismatch between the graft (knitted graft, length 40cm, diameter 16mm) and its labeling (woven graft, length 30cm, diameter 30mm) was confirmed.It was noticed that the blisters were not opened.((b)(4)) the corresponding mislabeled product was found in serbia and was returned as part of a previous complaint (see manufacturer report 1640201-2017-00012).Upon investigation and review of the complaint device history records, it appears that this discrepancy is related to an isolated human error which occured during a manufacturing step.As a corrective action, a working group is currently conducting an analysis of the issue to prevent such incident from reoccurring.
Event or Problem Description
It has been stated by the hospital that there was a different product in the package than the 30 mm graft mentioned on the product labeling.The primary packaging has not been opened.It has been suspected to be a 10 mm or 12 mm graft inside the package.It should be noted that the complaint situation was received by the (b)(4) affiliate on june 2, 2016 but has not been forwarded to the intervascular designated complaint handling unit.This complaint situation was received by the intervascular designated complaint handling unit on april 25, 2017 upon investigation of a previous product mix-up complaint (manufacturer report 1640201-2017-00012).

• 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: 6543325
• Report Number: 1640201-2017-00013
• Device Sequence Number: 749576
• Product Code: DSY
• UDI-Device Identifier: 00384401000266
• UDI-Public: 00384401000266
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 05/04/2017

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: 07/31/2020
• Device Model Number: INTERGARD WOVEN GRAFT
• Device Catalogue Number: IGW0030-30
• Device Lot Number: 15H06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2016
• Initial Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1