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

Catalog Number	636006P
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No known impact or consequence to patient: no reported significant delay to procedure, patient consequence or harm.Blushing/bleeding was repaired with application of bioglue and patient reported as stable post op.Information from the customer indicated that the device was not rinsed in saline for 5 minutes prior to use.Device handling problem - ifu states that failure to rinse for 5 minutes could lead to the graft being more susceptible to leakage when implanted.Vascutek ltd, now considers this complaint closed.Further action is 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.
Event or Problem Description
The event was reported as follows: after suturing of the graft and graft supply restoring, there was leakage through the graft noticed.Doctor waited for 15 minutes but the oozing did not stop.The glue was applied to stop leakage.

• 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: 8886818
• Report Number: 9612515-2019-00022
• Device Sequence Number: 335269
• Product Code: DSY
• UDI-Device Identifier: 05037881115023
• UDI-Public: 05037881115023
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2019
• Report Date (Section F): 07/19/2019

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: 636006P
• Device Lot Number: 17580435
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/13/2019
• 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
• Patient Age: 60 YR
• Patient Weight: 55