MAUDE Adverse Event Report: VASCUTEK LTD FLUOROPASSIV CAROTID PATCH

Catalog Number 921010FT

Device Problem Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation was completed and showed no adverse trends.A review of manufacturing records could not confirm if the device was manufactured to the correct length as in 2015 dhrs did not list length measurements and procedure stated that only (b)(4) of the batch were required to be measured.New version of dhrs for fluoropassiv tapered patches require 100% length verification measurement.A 5-year review of similar events gave a low occurrence rate of (b)(4) (complaints v sales).(b)(4) complaints received from the same customer for the same lot number are first complaints for the short patch length.No negative trend in the number of complaints received identified.Location of all patches from the complaint lot was identified.It was confirmed that all patches were implanted in different hospitals in different countries.There were no other complaints for the patches being too short.The complaint device will not be returned to manufacturer as it is remains implanted within patient's anatomy.New dhrs that require 100% length check were introduced in june 2016 and no complaints were received for the patches manufactured after this change; therefore, further action is not planned.Vascutek consider this case closed.

Event Description

Customer reported event as follows: the 921010ft box was opened and it was noticed that the patch's length was smaller than the dimensions listed on the box.The patch size was in fact 10mm x 75mm (instead of 10mm x 100mm).Fortunately the carotid incision was a smaller one so that the reduced length didn't cause any issues during the procedure.

• Brand Name: FLUOROPASSIV CAROTID PATCH
• Type of Device: FLUOROPASSIV CAROTID PATCH
• 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: 7930426
• MDR Text Key: 122640969
• Report Number: 9612515-2018-00017
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K972201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/07/2018,10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 921010FT
• Device Lot Number: 362015/01 8007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/30/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2018
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2015
• 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
• Patient Age: 73 YR
• Patient Weight: 85