MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	633008
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Leakage of blood from 8 mm knitted dacron graft by vascutec.

• Brand Name: GELSOFT GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS STRAIGHT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): VASCUTEK LTD; 799 international parkway; sunrise FL 33325
• MDR Report Key: 17764029
• Report Number: 17764029
• Device Sequence Number: 7093867
• Product Code: DSY
• UDI-Device Identifier: 05037881110240
• UDI-Public: (01)05037881110240
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2023
• Report Date (Section F): 07/27/2023

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 Model Number: 633008
• Device Catalogue Number: 633008
• Device Lot Number: 21476737-3499
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/27/2023