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	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported that "after the pci procedure in patient's calcified, moderately tortuous rca, user removed the twin-pass catheter from the patient and observed the distal tip of the catheter rapid exchange lumen is dampened.User concerned some parts of the tip dislodged and remained in the vessel and thus performed another stenting to cover the site.The patient was reported as fine.".
Additional Manufacturer Narrative
Qn #(b)(4).One-unit of twin pass (lot73j2300823) was returned for evaluation.Blood particulates were noted on the unit.Approximately 1 cm of tip was observed to be sheared off and missing.Guidewire lumen damages were observed.Damages are likely to have occurred during use in the procedure and operated against resistance with other devices.As per additional information received, the physician used the twinpass for a bifurcation wiring technique.Additional stenting was done to cover the site.Per device return, it is evident to note tip was missing.Distal end and guidewire lumen damages are indicative of the operation and interaction with other device against resistance.The ifu along with the product 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 manufacturing record review was completed, and no related non-conformances were found.Based on the information, the most likely r oot cause of the issue is operational context and/or unintended use error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that "after the pci procedure in patient's calcified, moderately tortuous rca, user removed the twin-pass catheter from the patient and observed the distal tip of the catheter rapid exchange lumen is dampened.User concerned some parts of the tip dislodged and remained in the vessel and thus performed another stenting to cover the site.The patient was reported as fine.".

• 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 MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20461603
• Report Number: 2134812-2024-00054
• Device Sequence Number: 15402265
• Product Code: DQY
• UDI-Device Identifier: 10841156107390
• UDI-Public: (01)10841156107390(11)231120(17)250925(10)73J2300823(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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 09/25/2025
• Device Catalogue Number: 5200
• Device Lot Number: 73J2300823
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown