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

Model Number	5566
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: advanced trapliner through hemostatic valve and trapliner snapped/broke off.Retrieved from the patient by pulling back; no snare used.No harm to patient from as pulled out at beginning when advancing in hemostatic valve.Lot unknown.
Additional Manufacturer Narrative
A follow-up report will be issued after the investigation is complete.
Additional Manufacturer Narrative
One-unit of trapliner was returned for evaluation.Blood particulates were found on the catheter.Weld joint separation was confirmed.Minor wire wrap damage was observed on the halfpipe lumen of the collar.The point of weld separation was measured from proximal hub end (i.E., only working length of the pushrod).The top-level assembly traveler was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.The physician advanced trapliner through hemostatic valve.The trapliner snapped/broke off.The damages are likely to have occurred during use in the procedure.Per ifu states the following warning and precaution: - 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 additional information was requested from the account.A response was received.The snapped portion was pulled back.No snare or intervention needed.No issues noted while prepping the catheter.No patient harm noted.Based on the information, 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
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 14983341
• Report Number: 2134812-2022-00045
• Device Sequence Number: 20089194
• Product Code: DQY
• UDI-Device Identifier: 10841156102128
• UDI-Public: 10841156102128
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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: 04/26/2022
• Device Model Number: 5566
• Device Catalogue Number: 5566
• Device Lot Number: 717546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown