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

Model Number	IGW0026-30
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.It was confirmed that the product itself measured 15 cm instead of 30 cm as labeled.((b)(4)) the review of the device history records and the investigation performed indicated that the issue is related to human errors occuring during manufacturing steps.The capa system has been initiated in order to take appropriate corrective actions.
Event or Problem Description
It was reported that the graft has a length of about 10 cm whereas the label indicates a 30 cm length.The product was in the distributor warehouse and was not sold to any hospital.Please note that the event was reported to the designated complaint unit on april 27, 2017.The involved product was received for evaluation on may 30, 2017.

• 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: 6601169
• Report Number: 1640201-2017-00016
• Device Sequence Number: 802090
• Product Code: DSY
• UDI-Device Identifier: 00384401000228
• UDI-Public: 00384401000228
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2017

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: 03/31/2021
• Device Model Number: IGW0026-30
• Device Catalogue Number: IGW0026-30
• Device Lot Number: 16D21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1