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

Model Number	HGK0010-70
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(10/3317/213) a review of the device history records indicated that the graft was processed and inspected according to established tests and procedures and no anomaly was found.These tests include a 100% visual inspection of the graft.In addition, no anomaly was evidenced in the collagen coating records.The review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications.(3340/3345/213) one retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso 7198.The test result indicated a value well within product specifications.All available information and the testing performed on similar products would tend to indicate that the device was not defective at the time of manufacturing.As reported by the surgeon, the puncture was highly probably caused at the time of use of the device.
Event or Problem Description
During a surgery performed on (b)(6) 2016, a small source of bleeding was noted in the graft.The surgeon had to place an additional stitch to close the hole in the graft to achieve hemostasis.The graft remained implanted.No adverse patient consequence was reported.The surgeon indicated that the puncture could have been caused by a clamp or other surgical instruments during implantation.He stated that he did not feel the event was a failure of the graft.
Additional Manufacturer Narrative
The unused remaining fragment of the involved device was returned for evaluation.The quality inspection of the fragment performed by our quality assurance supervisor did not evidence any structural abnormality such as hole or drop stitch (textile defect).In addition, the examination performed by the manufacturing textile supervisor confirmed that the observed fragment did not present any structural abnormality.This evaluation confirmed that the reported hole in the implanted graft was of an isolated nature and, as reported by the surgeon, was highly probably caused at the time of use of the device, during surgery.

• 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: 5986452
• Report Number: 1640201-2016-00029
• Device Sequence Number: 19235706
• Product Code: DSY
• UDI-Device Identifier: 00384401014225
• UDI-Public: 00384401014225
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 01/31/2021
• Device Model Number: HGK0010-70
• Device Catalogue Number: HGK0010-70
• Device Lot Number: 16B18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2016
• Supplement Report FDA Received Date: 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention