MAUDE Adverse Event Report: VASCUTEK LTD MAXIFLO

Catalog Number	T8008E
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of manufacturing and qc records confirmed that the device was manufactured to specification.A 5-year review of similar events gave an occurrence rate of (b)(4) (complaints v sales).No negative trend in the number of complaints received was identified.Additional information was requested from the surgeon to allow further investigation.
Event or Problem Description
The event was reported as graft being torn during implantation.
Additional Manufacturer Narrative
Method code: 4114 - device not returned.Result code: 3221 - no finding available.Conclusion code: 4315 - cause not established.The root cause of the event could not be identified as device was not available for further analysis and additional information was not received from the customer.Three attempts ((b)(6) 2019) were made to obtain additional information about the event.Further action is not planned; 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.Vascutek ltd consider this case closed.
Event or Problem Description
This report is being submitted as follow up # 1 for mfr.Report # 9612515-2019-00016 to provide closure information for the case.

• Brand Name: MAXIFLO
• Common Device Name: MAXIFLO
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8762623
• Report Number: 9612515-2019-00016
• Device Sequence Number: 19463734
• Product Code: DSY
• UDI-Device Identifier: 05037881151380
• UDI-Public: 05037881151380
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K030999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2019
• Report Date (Section F): 06/06/2019

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: 04/30/2024
• Device Catalogue Number: T8008E
• Device Lot Number: 17769258 2044
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1