MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TWIN-PASS V2; CATHETER, PERCUTANEOUS

Catalog Number	5200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "stented lad, lost side branch- attempted to wire side branch with twin pass.Wired side branch successfully, removed twin pass, then noticed 11mm of the tip was broken off, wired distal lad balloon pulled loose tip back into guide, re-sheathed and removed successfully.No changes to vitals throughout.There was no reported patient harm or health consequence.".
Additional Manufacturer Narrative
(b)(4).The customer report of device tip separation was able to be confirmed by visual inspection of the customer supplied photos.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.As per the additional information received, the lad was stented, but the side branch was lost.The twin-pass was used to wire the side branch successfully.Upon removal the twin-pass tip was noticed broken off.The catheter was prepped and flushed without any issues.11mm of the tip was separated.The lumen locked onto the guidewire with no resistance.There was no structural damage to the lumen.There was no harm to the patient, and the twin-pass catheter and tip were entirely removed from the vessel.It's possible the twin pass was caught on the stent and separated upon removal.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "stented lad, lost side branch- attempted to wire side branch with twin pass.Wired side branch successfully, removed twin pass, then noticed 11mm of the tip was broken off, wired distal lad balloon pulled loose tip back into guide, re-sheathed and removed successfully.No changes to vitals throughout.There was no reported patient harm or health consequence.".

• Brand Name: TWIN-PASS V2
• 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: 23221088
• Report Number: 2134812-2025-00035
• Device Sequence Number: 9410035
• Product Code: DQY
• UDI-Device Identifier: 10841156100353
• UDI-Public: (01)10841156100353(11)240423(17)260423(10)73D2400991(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083784
• 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): 09/10/2025

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: 04/23/2026
• Device Catalogue Number: 5200
• Device Lot Number: 73D2400991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2024
• 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 Age: 59 YR
• Patient Sex: Unknown