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

Catalog Number 636006P

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2019

Event Type  malfunction  

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 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
• Type of Device: GELSOFT PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 8886818
• MDR Text Key: 200814500
• Report Number: 9612515-2019-00022
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115023
• UDI-Public: 05037881115023
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2019,08/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 636006P
• Device Lot Number: 17580435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2018
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 55