MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TRAPLINER; CATHETER

Model Number	5567
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
It was reported that there was very, long and complicated case (cto) and they used a lot of devices.They used trapliner and it broke off in the place of shaft and half-pipe part.They took out the trapliner with a microcatheter and used new trapliner and continued.The preparation was ok, doctor is very experienced, and a second trapliner helped.The patient was not injured.Cto successfully completed.No further complications were reported.
Additional Manufacturer Narrative
No product was returned for investigation.A returned product evaluation was not completed.A manufacturing record review was completed and no related non-conformances were found.The account sent pictures of the used trapliner.Based off the pictures, it can be noted that guide extension lumen completely delaminated from the push rod.The weld joint was intact.The half pipe collar transition was damaged.Another device was found to be inside the guide extension.No other damage was observed.Per ifu the warning states," never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury".The account was inquired if resistance was felt in the shaft.No response was received.A nonconformance request was initiated to investigate the complaint issue.A supplier manufacturing/process issue was noted with the trapliner backbone in addition to operational use of the catheter in the procedure.A supplier corrective action has been issued to capture changes.Teleflex will continue to monitor and trend reports for any similar events.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10465277
• Report Number: 2134812-2020-00052
• Device Sequence Number: 11360473
• Product Code: DQY
• UDI-Device Identifier: 20841156102132
• UDI-Public: (01)20841156102132
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: 5567
• Device Lot Number: 669473
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/24/2021
• 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: Required Intervention
• Patient Age: 63 YR