MAUDE Adverse Event Report: VASCUTEK LTD. GELSEAL STRAIGHT GRAFT

Model Number	431508
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: process evaluation - a review of the manufacturing process was carried out and no issues were identified.Manufacturing review - a complete review of the manufacturing and qc records did not identify any issues with the manufacture of the device.Sterilisation process review - a review of the sterilisation records for this device confirmed that all acceptance criteria were met.Evaluation, results: pending completion of evaluation - the device has been returned to vascutek and analysis is currently ongoing.The results of the analysis will be included in the next report.Conclusion: conclusion not yet available evaluation in progress- the device has been returned to vascutek and analysis is currently ongoing.The results of the analysis and a conclusion will be included in the next report.
Event or Problem Description
It was reported to vascutek that a gelseal straight graft was bleeding through during the case.No further information has been provided to date.
Additional Manufacturer Narrative
(b)(4).Vascutek now considers this complaint closed, however the issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action may be taken at that time.
Event or Problem Description
This record is a follow up #1 report regarding mfr#9612515-2017-00004 that was submitted to the fda on february 23rd 2017.

• Brand Name: GELSEAL STRAIGHT GRAFT
• Common Device Name: GELSEAL STRAIGHT GRAFT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6351998
• Report Number: 9612515-2017-00004
• Device Sequence Number: 11007205
• Product Code: DSY
• UDI-Device Identifier: 05037881100340
• UDI-Public: 05037881100340
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P890045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017
• Report Date (Section F): 01/27/2017

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: Other
• Device Expiration Date: 02/28/2021
• Device Model Number: 431508
• Device Catalogue Number: 431508
• Device Lot Number: 377293/01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Distributor Facility Aware Date: 01/27/2017
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 03/24/2017
• 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: Other