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	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "trapliner was inserted as usual.Upon first device exchange, the balloon was unable to enter the extension portion, and the entire system was removed.There was a collar separation, the hypotube did not visually appear damaged.It was unclear whether the collar separated during the exchange or if it had been damaged before use.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
Qn# (b)(4).The reported issue of trapliner collar separation was confirmed upon investigation of the returned sample.The customer returned one unit of trapliner for evaluation.Partial delamination of proximal halfpipe was observed.Significant deformation was observed on the lumen of the halfpipe.Lumens were pinched together.The damages are likely to have occurred during use in the procedure.The ifu notes 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 in injury.The additional information indicated that corsair pro xs was observed to have concomitant device interaction issues with trapliner.No patient harm noted.A device history record review was performed, and no relevant findings were identified.Based on the information, the most likely root cause of the issue is unintended use error.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "trapliner was inserted as usual.Upon first device exchange, the balloon was unable to enter the extension portion, and the entire system was removed.There was a collar separation, the hypotube did not visually appear damaged.It was unclear whether the collar separated during the exchange or if it had been damaged before use.There was no reported patient harm or consequence.".

• 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
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22518683
• Report Number: 2134812-2025-00025
• Device Sequence Number: 7951823
• Product Code: DQY
• UDI-Device Identifier: 10841156100544
• UDI-Public: (01)10841156100544(11)240930(17)260930(10)47J2400537(21)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 09/30/2026
• Device Catalogue Number: 5566
• Device Lot Number: 47J2400537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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 Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 91 KG