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

Model Number HGK25/75P (1)

Device Problems Crack (1135); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

The patch was found dried and cracked.The surgeon used another patch to perform the surgery.No patient injury was reported.

Manufacturer Narrative

A review of the device history records, including collagen coating and rinsing steps records, indicated that the patch was processed and inspected according to procedures and no anomaly was found.The returned device was inspected by the qa/qc manager.The device, as it was returned, does not conform with the specification and was found with an unusual aspect and stiff.One retention sample rinsed on the same rinsing bath as the complaint device was inspected by the qa/qc manager.No anomaly was found.Additional information is being seeked.A follow-up will be sent upon conclusion of the investigation.

Manufacturer Narrative

Additional information received from the nurse indicated that the patch was rinsed with saline heparinized solution before the procedure.Therefore, the patch was received in conditions preventing the evaluation of the reported event.The most probable cause of the reported event is that the patch was allowed to dry after rinsing.

Event Description

Additional information received on march 26, 2015 indicated that the product was rinsed with saline heparinized solution before the procedure.

• Brand Name: HEMAGARD KNITTED PATCH
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 1370 5; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 1370 5; FR 13705
• Manufacturer Contact: pascal de framond ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208779
• MDR Report Key: 4633882
• MDR Text Key: 5754192
• Report Number: 1640201-2015-00013
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2017
• Device Model Number: HGK25/75P (1)
• Device Catalogue Number: HGK25/75P (1)
• Device Lot Number: 12C15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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