MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED; VASCULAR POLYESTER GRAFT

Model Number	HGK0012-40
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for evaluation.A mismatch between the returned graft (woven graft, length 15 cm, diameter 30 mm) and its labeling (knitted graft, length 40 cm, diameter 12 mm) was confirmed.A non-conforming report has been initiated in order to identify the root cause and take appropriate corrective actions.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
During the preparation of a procedure on (b)(6) 2017, it was reported that the diameter of the graft was significantly greater than labeled on the package.The device was not used and was returned for evaluation.
Additional Manufacturer Narrative
The conducted investigation concludes that the root cause is a product mix-up.The suspected device located in (b)(4) was returned as part of a recall.No other product was involved in this issue.

• Brand Name: HEMAGARD KNITTED
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6676442
• Report Number: 1640201-2017-00020
• Device Sequence Number: 816209
• Product Code: DSY
• UDI-Device Identifier: 00384401014249
• UDI-Public: 00384401014249
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: 12/31/2020
• Device Model Number: HGK0012-40
• Device Catalogue Number: HGK0012-40
• Device Lot Number: 16A28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1