MAUDE Adverse Event Report: VASCUTEK LTD GLSOFT; GELSOFT PATCH

Model Number	GELSOFT PATCH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
This event was reported via the panther study reported wound complications following implantation of a cardiovascular patch in the femoral area.The site reported possible infection despite negative test results by the sites lab testing.
Additional Manufacturer Narrative
Investigation findings - 213 - no device problem was found.Vascutek ltd completed review of the associated manufacturing and sterilisation records for these devices; all records indicate that they were manufactured and processed as per specifications.Investigation conclusion - 4315 - cause not established - for the following reasons 1.The investigation conducted by vascutek ltd.Concluded that the device was manufactured to specification.2.The reporting site tested the patient for signs of infection; none was found.3.The reporting site indicated that some redness is still present at the wound but is not clinically significant.Wound healing is good and antibiotics have been stopped 4.Review of the supplied ifu booklet with this device type indicates that fever and localised inflammation of surgical sites are a known and expected outcome/adverse event associated with the implantation of gelsoft branded grafts.Vascutek considers this event as closed as no further investigation is possible.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
This event was reported via the panther study.Reported wound complications following implantation of a cardiovascular patch in the femoral area.The site reported possible infection despite negative test results by the sites lab testing.

• Brand Name: GLSOFT
• Common Device Name: GELSOFT PATCH
• 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: 13007987
• Report Number: 9612515-2021-00029
• Device Sequence Number: 14812826
• Product Code: DXZ
• UDI-Device Identifier: 05037881010656
• UDI-Public: 05037881010656
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K963611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: GELSOFT PATCH
• Device Catalogue Number: 960701-G
• Device Lot Number: 18066428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown