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

Model Number HGKAX0808

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

Device is not accessible for testing as it remained implanted in the patient.A review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating records.Moreover, 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 (< 5 ml/cm²/min).Water permeability testing of a retention sample from same lot and coated on the same day and under the same conditions as the involved device is pending.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

The customer is reporting a bleeding event during surgery.A significant bleeding was observed throughout the entire graft body at the time of bypass release.The customer clamped and after a while, declamped again, and the bleeding stopped.

Manufacturer Narrative

(11/213) one retention sample from the same lot and coated on the same day and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).(67) the cause of the event remains unknown.However, the conducted investigation and the testing performed suggest that the product was not defective.(22) please note that blood leakage is a foreseeable side-effect as indicated in the instructions for use.

• Brand Name: HEMAGARD KNITTED
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8357088
• MDR Text Key: 139341199
• Report Number: 1640201-2019-00009
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401015109
• UDI-Public: 00384401015109
• Combination Product (y/n): N
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2022
• Device Model Number: HGKAX0808
• Device Catalogue Number: HGKAX0808
• Device Lot Number: 17G06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1