MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE COSELLI THORACOABDOMINAL 4 BRANCH

Model Number GELWEAVE

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, the patient underwent a procedure to have a gelweave coselli thoracoabdominal graft implanted.During the procedure, the clinician reported that the right renal branch root was leaking.Protamine was applied to arrest the leak, which was unsuccessful.The clinician then applied a suture to the affected area and completed the procedure without any further incident.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE COSELLI THORACOABDOMINAL 4 BRANCH
• 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: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 7905082
• MDR Text Key: 121569859
• Report Number: 9612515-2018-00013
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881107233
• UDI-Public: 05037881107233
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2018,09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: GELWEAVE
• Device Catalogue Number: 732410108/8S4
• Device Lot Number: 17292242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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): Other