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

Model Number	5568
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
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
As reported: during the procedure a trapliner 8fr was used and got caught on the watchdog/copilot and split apart.The procedure was completed with a different device.No medical intervention was required.Patient discharged to home with no sequelae.
Additional Manufacturer Narrative
Device returned for investigation.The device lot history record review indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.The event description states trapliner got caught on the hemostasis valve and split apart.The half pipe section was split from the proximal end to the collar transition section.The pushwire separated/delaminated from the halfpipe lumen.The rx shaft was damaged with the lumen bulging out.This is likely due to torque damage.Minor bends were noted on the pushwire.The tip of the catheter had minor damages.The damage noted on the catheter is likely to have occurred during use with other devices and concomitant device interaction.Per ifu, a warning and precaution are stated as of the following: 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.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking.Do not apply torque to the catheter during delivery, as catheter damage may result.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 55369
• MDR Report Key: 10577181
• Report Number: 2134812-2020-00062
• Device Sequence Number: 3545970
• Product Code: DQY
• UDI-Device Identifier: 20841156102149
• UDI-Public: (01)20841156102149
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 08/02/2020

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: 04/06/2022
• Device Model Number: 5568
• Device Lot Number: 671067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 89