MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TWINPASS V2; DUAL ACCESS CATHETER

Model Number	5200
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.
Event or Problem Description
It was reported that: tip was sheared while going through a stent strut.It stayed on the wire and was removed from the patient.Patient was reported as fine.Additional information has been requested from the account.
Event or Problem Description
It was reported that: tip was sheared while going through a stent strut.It stayed on the wire and was removed from the patient.Patient was reported as fine.Additional information has been requested from the account.
Additional Manufacturer Narrative
(b)(4).One-unit of twinpass was returned to vsi/teleflex for evaluation.Blood particulates were noted on the unit.Approximately 0.8 cm of tip was observed to be sheared off and missing.Lumen was observed to be longitudinally split.A device history record review was completed.All processes were followed.No non-conformances noted case details and medwatch report were reviewed.Customer stated that the" tip of the twinpass sheared while going through a stent strut".Per medwatch report, "physician was not able to reinsert wire into the catheter system.He noticed the tip broke off." one-unit of twinpass was returned to vsi/teleflex for evaluation.Approximately 0.8 cm of tip was observed to be sheared off and missing.Lumen was observed to be longitudinally split.Damages are likely to have occurred during use in the procedure and operated against resistance with other devices.Per ifu states the following warning and precaution: 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.Additional information was requested.A response was received.The physician used the twinpass for a bifurcation wiring technique.The tip got buckled up trying to o through a stent strut.The tip broke off but stayed on the wire.It was removed from the body.No piece was left behind in the vessel.No intervention was performed.Per device return, it is evident to note tip was missing.Distal end and guidewire lumen damages are indicative of the operation & interaction with other device against resistance.A manufacturing record review was completed by tecate and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: TWINPASS V2
• Common Device Name: DUAL ACCESS CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16625956
• Report Number: 2134812-2023-00014
• Device Sequence Number: 11876641
• Product Code: DQY
• UDI-Device Identifier: 10841156107390
• UDI-Public: 10841156107390
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: 06/07/2024
• Device Model Number: 5200
• Device Catalogue Number: 5200
• Device Lot Number: 73F2200294
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown