MAUDE Adverse Event Report: VASCUTEK GELSOFT; GELSOFT DOUBLE BIFURCATE

Model Number	631809DB
Medical Device Problem Codes	Leak/Splash (1354); Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional narrative: a preliminary investigation was completed which showed no issues or adverse trends.The review of manufacturing & qc records showed that the graft was manufactured to specification.The whole graft porosity results were well below the maximum limits.A 5 year review of similar reported gelsoft events gave a low occurrence rate of (b)(4).There have been no similar events reported for units of the same batch (3 units in batch).As the device remains in situ within the patient a physical analysis is not possible.The root cause of the event was not identified.Further action is not planned, 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.Vascutek consider this case closed.
Event or Problem Description
It was reported that when blood flowed after the graft was anastomosed, there was leakage from a point in each of the graft limbs (two points in total).One leakage was stopped by pressing with fingers.The other leakage was stopped by applying a stitch.Nothing was performed in the branch parts until the leakage was found.A clamp or other appliances with a sharp point was not used.When the procedure was completed, there was no blood leakage.There was no patient consequence as a result of the event.It was confirmed that a size 4-0 prolene needle was used and that the graft was not soaked in saline prior to use, but saline was sprayed over the graft with a syringe.

• Brand Name: GELSOFT
• Common Device Name: GELSOFT DOUBLE BIFURCATE
• Manufacturer (Section D): VASCUTEK; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6331089
• Report Number: 9612515-2017-00003
• Device Sequence Number: 1106092
• Product Code: DSY
• UDI-Device Identifier: 05037881110011
• UDI-Public: 05037881110011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2017
• Report Date (Section F): 01/17/2017

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: 01/31/2021
• Device Model Number: 631809DB
• Device Catalogue Number: 631809DB
• Device Lot Number: 377604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 02/15/2017
• 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: Required Intervention