MAUDE Adverse Event Report: INTERVASCULAR HEMAGARD KNITTED AXILLO BIFERMORAL GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number HGKAX0808RS45/20

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

During a vascular surgery performed on (b)(6) 2014, the graft was reported to bleed more than usual.The graft remained implanted and the surgery was completed without any adverse event for the pt.

Manufacturer Narrative

Method/results: a review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.One retention sample coated on the same period 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.Conclusions: no conclusions can be drawn.However, all available info and the product testing performed would tend to indicate that the device was not defective.

• Brand Name: HEMAGARD KNITTED AXILLO BIFERMORAL GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR; zone industrielle athelia i; laciotat 1360 5; FR 13605
• Manufacturer Contact: pascal framond ; zone industrielle athelia i; laciotat 13605 ; FR 13605 ; 42084646
• MDR Report Key: 4360640
• MDR Text Key: 5117784
• Report Number: 1640201-2014-00037
• Device Sequence Number: 1
• Product Code: DSY
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: HGKAX0808RS45/20
• Device Catalogue Number: HGKAX0808RS45/20
• Device Lot Number: 13H29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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