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

Model Number HGK0010-70

Device Problem Hole In Material (1293)

Patient Problem Blood Loss (2597)

Event Date 09/01/2016

Event Type  Injury  

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 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.

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
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: laure fraysse ; zi athélia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 5986452
• MDR Text Key: 55888611
• Report Number: 1640201-2016-00029
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014225
• UDI-Public: 00384401014225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention