MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TRAPLINER 8F; CATHETER, PERCUTANEOUS

Catalog Number	5568
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: during a procedure, the rt prepping the trapliner flushed the device.The rt noted that the tip was separated.The device was never inserted into the patient.It was set aside and another 8f trapliner was prepped and used to complete the procedure.
Additional Manufacturer Narrative
(b)(4) one-unit of trapliner (m5568 lot 47b2400243) was returned to for evaluation.Blood particulates were noted within the lumen.Unit was decontaminated and inspected.Weld joint separation was confirmed.The halfpipe lumen was observed to be pinched inwards.No tip separation noted.The top-level assembly traveler (rt103622, lot 47b2400243) 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" during a procedure, the rt prepping the trapliner flushed the device.The rt noted that the tip was separated.The device was never inserted into the patient." 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.It is unknown to what extent and rigor the catheter was subjected to preparation.No additional information was provided by the customer.Signs of lumen pinched inwards indicate the catheter has subjected to strenuous use.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.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: during a procedure, the rt prepping the trapliner flushed the device.The rt noted that the tip was separated.The device was never inserted into the patient.It was set aside and another 8f trapliner was prepped and used to complete the procedure.

• Brand Name: TRAPLINER 8F
• 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: 19211327
• Report Number: 2134812-2024-00021
• Device Sequence Number: 7016670
• Product Code: DQY
• UDI-Device Identifier: 10841156100568
• UDI-Public: 10841156100568
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 04/03/2024

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: 02/23/2026
• Device Catalogue Number: 5568
• Device Lot Number: 47B2400243
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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