MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT; GELSOFT GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS

Model Number	GELSOFT BIFURCATE
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report is being submitted as an initial / final report.As no device is being returned for further investigation, vascutek ltd.Now considers this complaint closed 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
Event was reported to vascutek ltd.As follows: "after blood flow release the graft showed a leakage at the sight of the bifurcate junction.The surgeon applied a few stitches to stop the bleeding".

• Brand Name: GELSOFT
• Common Device Name: GELSOFT GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8419600
• Report Number: 9612515-2019-00003
• Device Sequence Number: 16203041
• Product Code: MAL
• UDI-Device Identifier: 05037881110462
• UDI-Public: 05037881110462
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P890045/S1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2019
• Report Date (Section F): 02/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: GELSOFT BIFURCATE
• Device Catalogue Number: 631608-G
• Device Lot Number: 17601138-1664
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR