MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TURNPIKE LP; CATHETER

Model Number	5638
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: the microcatheter was used to support wiring of totally occluded rca, but it was broken easily despite gentle use and handling".The microcatheter was introduced until a certain point and no more advancement was done and it broke, the whole device was removed without any separation.Reported that no consequences were caused by the device problem and no medical intervention.
Additional Manufacturer Narrative
Manufacturing records will be reviewed.A follow-up report will be issued after the investigation is complete.
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.The device history record was reviewed.There are no nonconformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.A patient underwent a pci procedure.The vessel was cto of rca.A turnpike lp was used in the case to support wiring that broke easily despite gentle use and handling.It is unknown what damages the turnpike lp incurred.It is unknown if the tip or the shaft broke during the case.Additional information was requested from the account.A response was received.It is unknown if the tip was trapped and over torqued.The microcatheter was advanced up to a certain point and no more advancements could be done leading to breakage.Account stated that the whole device was removed without any separation.It is unclear what "broke or breakage refers to per complaint details".It is likely that device broke and removed with the guidewire wire.However, this cannot be confirmed without product evaluation.No part remained in the patient.No force was used with catheter.Another turnpike and a competitor microcatheter were used to complete the procedure.No medical consequences observed.Based on the information, the most likely root cause of the issue is undeterminable.

• Brand Name: TURNPIKE LP
• Common Device Name: 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: 13261708
• Report Number: 2134812-2022-00010
• Device Sequence Number: 1701759
• Product Code: DQY
• UDI-Device Identifier: M20656380
• UDI-Public: M20656380
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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: 05/07/2021
• Device Model Number: 5638
• Device Lot Number: 648328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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 Age: 50 YR
• Patient Sex: Male