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

Model Number GELSOFT BIFURCATE

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)

Patient Problem Blood Loss (2597)

Event Date 02/13/2019

Event Type  malfunction  

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 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
• Type of Device: GELSOFT GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS
• 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: 8419600
• MDR Text Key: 139104512
• Report Number: 9612515-2019-00003
• Device Sequence Number: 1
• Product Code: MAL
• UDI-Device Identifier: 05037881110462
• UDI-Public: 05037881110462
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P890045/S1
• 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: 02/14/2019,03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• 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
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• 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): Required Intervention
• Patient Age: 58 YR