MAUDE Adverse Event Report: VASCUTEK LTD MAXIFLO

Catalog Number T8008E

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 06/10/2019

Event Type  malfunction  

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 Description

The event was reported as graft being torn during implantation.

Event Description

This report is being submitted as follow up # 1 for mfr.Report # 9612515-2019-00017 to provide closure information for the case.

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.

• Brand Name: MAXIFLO
• Type of Device: MAXIFLO
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8762621
• MDR Text Key: 150157252
• Report Number: 9612515-2019-00017
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881151380
• UDI-Public: 05037881151380
• Combination Product (y/n): N
• PMA/PMN Number: K030999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/10/2019,09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 06/10/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2019
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1