MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS STRAIGHT

Catalog Number	636008P-G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of manufacturing and qc records confirmed that the device was manufactured to specification.Porosity test results for the whole batch of 8 were below the maximum flow of 53ml/min, with minimum result 0ml/min and maximum result 26ml/min.A five-year review of leakage in knitted grafts gave a low occurrence rate of 0.023% (complaints v sales).Additional information and affected device requested from the customer to allow further investigation of the event.Complaint investigation results will be provided in final report.
Event or Problem Description
Vascutek ltd.Was notified of an event that occurred in (b)(6), the event was described as follows: graft does not have vascular permeability, this was causing outflow of blood after unclamping the artery, causing exudation (oozing).
Additional Manufacturer Narrative
Additional information obtained: the customer advised that the graft was not pre soaked prior to its use: as per ifu recommendations which states: "the prosthesis must be immersed in a sterile saline solution for 5 minutes.Failure to rinse for 5 minutes could lead to the graft being more susceptible to leakage when implanted." method: 10 testing of actual device a 35cm section of the graft that was not used during the procedure was returned for testing (burst and porosity testing).Result: 213 no device problem testing of the returned section of the graft confirmed that it met specification.Conclusion: 4315 cause not established no issues or abnormalities were identified that could have caused or contributed to the reported defect.However, as the recommendation within the ifu was not followed, this may have contributed to the leakage reported by the user.Vascutek ltd consider this complaint closed now.Further actions are not planned; however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8826136
• Report Number: 9612515-2019-00020
• Device Sequence Number: 11390551
• Product Code: DSY
• UDI-Device Identifier: 05037881115047
• UDI-Public: 05037881115047
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019
• Report Date (Section F): 06/26/2019

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: 09/30/2021
• Device Catalogue Number: 636008P-G
• Device Lot Number: 17558691 1590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2019
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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