MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE SPIRAL 135CM; CATHETER, PERCUTANEOUS

Catalog Number	5640
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "turnpike spiral broke off inside patient during procedure." additional information has been requested from the customer.
Additional Manufacturer Narrative
(b)(4).Udi not complete as it was not provided by the customer.
Event or Problem Description
It was reported that "turnpike spiral broke off inside patient during procedure." additional information has been requested from the customer.
Additional Manufacturer Narrative
Qn #(b)(4).No return product evaluation could be completed as the device was not returned for investigation.It is unknown what damages were present on the unit and how much of tip separation was noted.A dhr review was completed for lot 73j2200514, and no issues or nonconformities were noted.Case details were reviewed.As per the additional information received, approximately 2 mm of tip separated.The vessel could still be wired with observed separation.Rotational atherectomy was performed.Very small portion embolized in vessel into a distal small branch artery.No harm noted to the patient.Procedure continued without further incident.The ifu states the following warning and precaution: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.Do not rotate the catheter more than two (2) consecutive 360 rotations in either direction if the distal tip is not also rotating and advancing, as it may result in separation of the catheter, damage to the catheter, or vessel injury.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking.It is likely that the turnpike tip was operated against resistance through a calcified vessel.Rotablating the remainder piece would fracture it to tiny particulates leading to embolization.Without a product return, it is unknown to what extent, degree, or rigor this device has seen use and handling.Based on the information, the most likely root cause of the issue undeterminable.The der process will continue to monitor for any similar events.

• Brand Name: TURNPIKE SPIRAL 135CM
• 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: 20083584
• Report Number: 2134812-2024-00041
• Device Sequence Number: 12662199
• Product Code: DQY
• UDI-Device Identifier: 10841156108755
• UDI-Public: (01)10841156108755(11)230120(17)240920(10)73J2200514(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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 Catalogue Number: 5640
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown