MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE STRAIGHT

Model Number	GELWEAVE STRAIGHT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; glasgow, PA4 9 RR,; UK PA4 9RR,
• MDR Report Key: 6666148
• Report Number: 9612515-2017-00008
• Device Sequence Number: 18843249
• Product Code: DSY
• UDI-Device Identifier: 05037881105079
• UDI-Public: 05037881105079
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2017
• Report Date (Section F): 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Distributor Facility Aware Date: 06/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other