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

Model Number	5200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
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: the tip broke off.Multiple requests have been sent for further information.No response at this time.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.A manufacturing record review was completed and no related nonconformances were found.The event description states tip of the twinpass broke off.No unit was returned for evaluation.It is unknown what damages occurred on the tip and shaft of the catheter.Additional information was requested from the account.No response was received.It is unknown if the tip was left out in the artery, how much of the tip separated and/or if the tip was retrieved.

• 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: 13373744
• Report Number: 2134812-2022-00017
• Device Sequence Number: 5184952
• Product Code: DQY
• UDI-Device Identifier: 10841156100353
• UDI-Public: 10841156100353
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 10/28/2022
• Device Model Number: 5200
• Device Catalogue Number: 5200
• Device Lot Number: 702907
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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