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

Model Number	5567
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: trapliner broke at, or near weld point during the procedure.Device was removed from the patient with no issues.Pulled out manually, was able to inflate a coronary balloon past the fractured piece, and pulled it back through the guide catheter, and out of the body.
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.One unit of trapliner,was returned for investigation.A returned product evaluation was completed.Only the rx lumen section of the trapliner was returned.Weld joint break was confirmed.It is unknown if any damages were present along the pushrod.The damages are likely to have occurred during use in procedure.Per ifu "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".Additional information was received from the account.Mild resistance was noted during the procedure.Ifu also states the following warning, "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." fragments were pulled out manually through the guide catheter without any issue.Based on the information and returned product evaluation, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10842972
• Report Number: 2134812-2020-00091
• Device Sequence Number: 11669951
• Product Code: DQY
• UDI-Device Identifier: 20841156102132
• UDI-Public: (01)20841156102132
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/18/2020

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: 07/16/2022
• Device Model Number: 5567
• Device Lot Number: 677138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 10/18/2020
• Supplement Date Received by Manufacturer: 10/18/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 100