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	Foreign Body In Patient (2687)
Date of Event	01/24/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported by clinical staff at the hospital that: patient had a "heavily calcified lad vessel.Turnpike spiral tip broke during procedure.Unable to retrieve." the patient's current condition is reported by staff at the hospital as deceased.The procedure was reported by clinical staff at the hospital to be a planned pci lad rotablation.Additional information has been requested from the hospital.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported by clinical staff at the hospital that: patient had a "heavily calcified lad vessel.Turnpike spiral tip broke during procedure.Unable to retrieve." the patient's current condition is reported by staff at the hospital as deceased.The procedure was reported by clinical staff at the hospital to be a planned pci lad rotablation.Additional information has been requested from the hospital.
Additional Manufacturer Narrative
(b)(4) no returned product evaluation could be completed as the product was not returned for evaluation.The top-level assembly traveler (rt107106, lot 73b2300104) was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.A patient (female 58y) underwent a percutaneous coronary intervention (pci) of left anterior descending (lad).The clinical staff at the hospital stated, "tip broke during the procedure".As per the additional information received, the patient was noted to have a medical history of conditions such as ckd, esrf, severe pvd, dm, severe triple vessel disease.Tip of the turnpike was left in the body.Remainder of the shaft was discarded.The ifu states the following warnings and precautions: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by f luoroscopy.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 unknown if the turnpike was operated against resistance.Tip material subjected excessive torque can fatigue the material leading to separation.No confirmation was provided by the customer.No pictures of the catheter or angiograms were shared.It is unknown how much of tip separated.The tip was not removed.A manufacturing record review was completed for lot 73b2300104 and no related nonconformances were found.Based on the limited information and no product returned, the most likely root cause of the issue is 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: 19087861
• Report Number: 2134812-2024-00012
• Device Sequence Number: 7819365
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: 10841156100704
• Combination Product (Y/N): N
• Initial Reporter Country: BX
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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 Expiration Date: 02/07/2025
• Device Catalogue Number: 5640
• Device Lot Number: 73B2300104
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/23/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 58 YR
• Patient Sex: Female