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	07/10/2026
Type of Reportable Event	Malfunction

• Brand Name: Twin-Pass V2
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): Vascular Solutions LLC; minneapolis MN
• Manufacturer (Section G): Teleflex Medical; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 50169042
• Report Number: 3003898360-2026-00363
• Device Sequence Number: 13271959
• Product Code: DQY
• UDI-Device Identifier: 10841156103842
• UDI-Public: (01)10841156103842(11)260129(17)280129(10)73A2601005
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K083784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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 Catalogue Number: 5200
• Device Lot Number: 73A2601005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male