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

Model Number	5200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been opened to review device history record and risk documentation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: tip of the twinpass sheared during use.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.The manufacturing record was reviewed.There are no nonconformances related to this lot therefore, supporting the device met material, assembly and performance specifications.It is unknown how much of the tip separated.It is undeterminable if any other damages occurred on the shaft.Additional information was requested from the account.A response was received.Account stated that the twin pass did not separate and was removed without the use of a snare.No tip was left in the vessel.Anatomical factors such as vessel calcification and tortuosity are unknown.No imaging or angiogram pertaining to the issue was shared.Based on the information, the most likely root cause of the issue is undeterminable.Another new twin pass was used to complete the procedure.Patient condition is stable post procedure.
Additional Manufacturer Narrative
Unit returned to vsi/teleflex on 11/29/2021 and inspected on 12/13/2021.Blood particulates were noted on the catheter.The lumen was kinked just distal to the guidewire lumen (i.E distal end of the lumen).No tip separation was observed.Tip was measured to be in specification.The damages are likely to have occurred during use in the procedure.Per ifu it states the following precaution.Exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking another new twinpass was used to complete the procedure.Patient condition is stable post procedure.Based on the new 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; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 12573645
• Report Number: 2134812-2021-00068
• Device Sequence Number: 1113606
• Product Code: DQY
• UDI-Device Identifier: 30841156100357
• UDI-Public: 30841156100357
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2021

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: 05/04/2021
• Device Model Number: 5200
• Device Lot Number: 709291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/16/2021; 09/16/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/22/2021; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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