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	04/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the twin pass was used for medication administration prepped and flushed with no issues.The marker tip sheared where the wire comes out.It was separated in two pieces.The twin pass was not removed in its entirety- the piece broke off in the distal tip of the vessel and we were unable to retrieve it there was no resolution.The remaining part of the twin pass was removed and the sheared piece remained in the vessel.".
Event or Problem Description
It was reported that: "the twin pass was used for medication administration prepped and flushed with no issues.The marker tip sheared where the wire comes out.It was separated in two pieces.The twin pass was not removed in its entirety: the piece broke off in the distal tip of the vessel and we were unable to retrieve it there was no resolution.The remaining part of the twin pass was removed and the sheared piece remained in the vessel.".
Additional Manufacturer Narrative
Qn #: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 22042476
• Report Number: 2134812-2025-00021
• Device Sequence Number: 8880579
• Product Code: DQY
• UDI-Device Identifier: 10841156100353
• UDI-Public: (01)10841156100353(11)230801(17)250801(10)73H2300003(21)
• Combination Product (Y/N): N
• PMA/510(K) Number: K083784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2025
• Device Catalogue Number: 5200
• Device Lot Number: 73H2300003
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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