MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE STRAIGHT

Model Number GELWEAVE STRAIGHT

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Patient underwent an ecmo (extracorporeal membrane oxygenation) procedure at the time of the reported issue.No patient consequence was reported by the site.(b)(4).Device was not returned to vascutek ltd.For evaluation, and no devices from the applicable batch was available for evaluation.Results: the review of the retained quality, manufacturing and labelling records confirmed that the product was manufactured to the intended specifications.Unapproved or contraindicated for use - gelweave grafts are designed for "systemic vascular repair" procedures and the method of use as defined by the user (ecmo) is not indicated within the ifu; thus its use was off-label.No further actions are required however, the issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action may be taken at that time.Device not returned to the manufacturer.

Event Description

Clinician had an issue with an 8mm gelweave graft on (b)(6) 2017 that was being used as part of an ecmo (extracorporeal membrane oxygenation) case.It was reported to be leaking throughout being described as a "soaker hose".The report also advised that the graft is not available for evaluation.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; glasgow, PA4 9 RR,; UK PA4 9RR,
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; glasgow, PA4 9 RR,; UK PA4 9RR,
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; glasgow, PA4 9-RR, ; UK PA4 9RR,
• MDR Report Key: 6666148
• MDR Text Key: 78409260
• Report Number: 9612515-2017-00008
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105079
• UDI-Public: 05037881105079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/15/2017,06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 731508
• Device Lot Number: 16091894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2017
• 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): Other