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

Model Number 633008

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

Leakage of blood from 8 mm knitted dacron graft by vascutec.

• Brand Name: GELSOFT GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS STRAIGHT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): VASCUTEK LTD; 799 international parkway; sunrise FL 33325
• MDR Report Key: 17764029
• MDR Text Key: 323606321
• Report Number: 17764029
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881110240
• UDI-Public: (01)05037881110240
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 07/27/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male