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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "tip of the spiral snapped off and doctor was able to retrieve it immediately." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Correction to section h: udi number.Device evaluation: one-unit of turnpike was returned to teleflex for evaluation.Blood particulates were noted on the unit.Unit was decontaminated and inspected.Approximately 0.4 cm of tip separation was confirmed.Tip material was fatigued and twisted.A dhr review was completed for lot 73a2300139, and no issues or nonconformities were noted.Case details were reviewed.Damages are likely to have occurred during use in the procedure.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.- exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking - 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.As per the additional information received, the patient was in good condition post procedure.Another turnpike was used to complete the case.Damages incurred by the turnpike is likely due to operation against resistance against a calcified lesion.Twisted tip material observed on the returned product is indicative of the tip subjected to torque with the material tethered in place.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.
Event or Problem Description
It was reported "tip of the spiral snapped off and doctor was able to retrieve it immediately." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• 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: 20097736
• Report Number: 2134812-2024-00043
• Device Sequence Number: 20749259
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: (01)10841156100704(11)2302115(17)250103(10)73A2300139(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 08/07/2024

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: 01/03/2025
• Device Catalogue Number: 5640
• Device Lot Number: 73A2300139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown