MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT PLUS BIFURCATE

Model Number 631608P

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: actual device not evaluated - the device was not returned to vascutek as it remains in situ within the patient.Manufacturing review- a complete review of the process, manufacturing and qc records was carried out which confirmed there were no issues with the manufacture of the device.Process review - a complete review of the process, manufacturing and qc records was carried out which confirmed there were no issues with the manufacture of the device.Sterilisation review- a review of the sterilisation records for this device was carried out which confirmed that the device was sterilised to specification.Results: no failure detected -no issue with the device could be identified from the investigation carried out by vascutek.A complete review of the process, manufacturing and qc records was carried out which confirmed there were no issues with the manufacture of the device.No results available since no evaluation performed - the device was not returned to vascutek as it remains in situ within the patient conclusion: unable to confirm complaint - vascutek are unable to confirm the complaint form the investigation carried out.Device not returned - the device was not returned to vascutek as it remains in situ within the patient.A review of previous complaints vs sales was carried out and the complaint rate for leakage of this product type is (b)(4).No adverse trends were identified form the review carried out.No further action will be taken at this time; however, the issue will be tracked and trended as part of the routine complaints monitoring process.If an adverse trend develops action may be taken at that time.Vascutek now considers this event closed.

Event Description

The event was described to vascutek as; when the clamp was released, blood leaked from the graft leg on the distal side 1 to 2 cm from the branch.Two bleeding points of needle hole size were found and sutures were applied.

• Brand Name: GELSOFT PLUS BIFURCATE
• Type of Device: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9-RR ; UK PA4 9RR ; 1418125555
• MDR Report Key: 6165663
• MDR Text Key: 62324685
• Report Number: 9612515-2016-00032
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115528
• UDI-Public: 05037881115528
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2016,12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 631608P
• Device Catalogue Number: 631608P
• Device Lot Number: 385316-8983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2016
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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