MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT BIFURCATE

Model Number GELSOFT BIFURCATE

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Terumo (b)(4) reported that a patient who had a gelsoft bifurcate implanted in 2007 had reported pain within the inguinal region (groin area).Investigation by the site confirmed that the graft had ruptured and blood leakage occurred (leakage location is unknown).The patient underwent an elective procedure where the ruptured area of the graft was anastomosed (sutured).The procedure was successful, and the patient is doing well.No device identification information or photos of the issue are available.

• Brand Name: GELSOFT BIFURCATE
• Type of Device: GELSOFT BIFURCATE
• 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: 8004401
• MDR Text Key: 124980254
• Report Number: 9612515-2018-00022
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990503
• 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: 10/18/2018,10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GELSOFT BIFURCATE
• Device Catalogue Number: 631408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2018
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2018
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention