MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TRAPLINER 6F; CATHETER, PERCUTANEOUS

Catalog Number	5566
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the tech said that the half pipe broke into 2 pieces separated inside the guide catheter.They had to pull everything out , it was trapped with a balloon and pulled out along with the guide catheter.There was no additional medical intervention needed due to product and no reported patient harm.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).One-unit of trapliner was returned for evaluation.Blood particulates were noted within the lumen.Unit was decontaminated and inspected.Weld joint separation was confirmed.Minor kink was noted on the halfpipe lumen near the collar.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.Customer stated" trapliner broke into 2 pieces".Damages are likely to have occurred during use and handling.The ifu states the following precaution: 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.As per the additional information received, the unit separated within the guide catheter.The separated piece was trapped with a balloon and pulled out along with guide catheter.No harm noted to the patient or anatomy.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: "the tech said that the half pipe broke into 2 pieces separated inside the guide catheter.They had to pull everything out , it was trapped with a balloon and pulled out along with the guide catheter.There was no additional medical intervention needed due to product and no reported patient harm.".

• Brand Name: TRAPLINER 6F
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18984970
• Report Number: 2134812-2024-00010
• Device Sequence Number: 20891010
• Product Code: DQY
• UDI-Device Identifier: 10841156100544
• UDI-Public: 10841156100544
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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: 07/03/2025
• Device Catalogue Number: 5566
• Device Lot Number: 726367
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown