MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; COSELLI THORACOABDOMINAL GRAFT

Model Number GELWEAVE

Device Problems Problem with Removal of Enzymatic Cleaner (1213); Shelf Life Exceeded (1567)

Patient Problems Not Applicable (3189); No Information (3190)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

The graft was labelled with an expiry date of 09/30/2015 but the cautery inside the packaging has already expired.Expiration date of cautery was 02/2014.

Manufacturer Narrative

Result: it was identified that the cautery that was provided with the gelweave graft has a shorter shelf life indicated on its label as that of the graft.Four years versus 5 years.In order to address the labeling deficiency, vascutek is proposing a field safety corrective action to remove the cautery from this product packaging and for this action to occur as a correction in the field.On the basis of the health hazard determination and in accordance with current fda guidelines on recalls, corrections and removals (devices), part 21 cfr806 "corrections and removals" this would be classed as a class ii recall, under the term of a correction/removal.A full report in accordance with fda part 806 (c) will be prepared and sent to the fda by (b)(4).

• Brand Name: GELWEAVE
• Type of Device: COSELLI THORACOABDOMINAL GRAFT
• Manufacturer (Section D): VASCUTEK LTD.; newmains ave.; inchinnan, renfrewshire ; UK
• Manufacturer Contact: steven arick ; 6200 jackson raod; ann arbor, MI 48103-9300 ; 7346634145
• MDR Report Key: 3983292
• MDR Text Key: 4635788
• Report Number: 9612515-2014-00010
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: GELWEAVE
• Device Catalogue Number: 732810108/8S4
• Device Lot Number: 117789 2920
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2010
• 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