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	Foreign Body In Patient (2687)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported issue tip separation was confirmed upon investigation of the returned sample.The customer returned one unit of twin pass catheter for evaluation.Approximately 9 mm of tip was separated.Deformation of polymer was noted on the separated tip at the proximal junction of separation.Polymer stress was noted near the distal exit port.The guidewire lumen was longitudinally split from the distal to the proximal ports.The damages are indicative of the catheter subjected to use against resistance.The ifu states: - never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter against resistance may result in catheter damage or vessel injury- exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.A device history record review was performed, and no relevant findings were identified.Additional information noted that no preparation issues observed.No unit was left inside the vessel.Based on the information, the most likely root cause of the issue is unintended use error.
Event or Problem Description
It was reported that: "user prepped and inserted the twin-pass dual access catheter to the target coronary artery according to the ifu.The catheter distal part was found dislodged inside the vessel during the pci and user decided to remove the defective catheter & the dislodged part by using the snare catheter.The removal of the defective catheter was successful and the twinpass catheter and tip were removed in entirety and nothing was left.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "user prepped and inserted the twin-pass dual access catheter to the target coronary artery according to the ifu.The catheter distal part was found dislodged inside the vessel during the pci and user decided to remove the defective catheter & the dislodged part by using the snare catheter.The removal of the defective catheter was successful and the twinpass catheter and tip were removed in entirety and nothing was left.

• 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: 23802604
• Report Number: 2134812-2025-00050
• Device Sequence Number: 18047843
• Product Code: DQY
• UDI-Device Identifier: 10841156103842
• UDI-Public: (01)10841156103842(11)240910(17)260910(10)73H2400893(21)
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K083784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 09/10/2026
• Device Catalogue Number: 5200
• Device Lot Number: 73H2400893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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