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

Model Number	5640
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "partial detachment of distal tip, recovered with no patient incident.The insertion site was radial artery.Clinical consequences: turnpike gold inserted to replace , and case proceeded to a successful outcome.The device was removed entirely and replaced.Another attempt was made successfully.This did not cause delay or harm/injury to the patient.".
Additional Manufacturer Narrative
(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.
Event or Problem Description
It was reported that: "partial detachment of distal tip, recovered with no patient incident.The insertion site was radial artery.Clinical consequences: turnpike gold inserted to replace and case proceeded to a successful outcome.The device was removed entirely and replaced.Another attempt was made successfully.This did not cause delay or harm/injury to the patient.".
Additional Manufacturer Narrative
Qn# (b)(4).One-unit of turnpike was returned to vsi/teleflex for evaluation.Blood particulates were noted on the unit.The tip of the turnpike was observed to be fatigued.The top-level assembly traveler 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.Customer stated the partial detachment of the tip was noted.One-unit of turnpike was returned to vsi/teleflex for evaluation.Blood particulates were noted on the unit.The tip of the catheter was observed to be fatigued.Damages are likely to have occurred during use when operated against a calcified lesion (cto of rca).Per 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.Additional information was requested.No response was received.Vessel was heavily calcified.The tip was not stuck in the cto.Customer stated" it seemed to dug-in and then the tip shredded".Device was removed and a turnpike gold was used to complete the case.No harm or injury noted to the patient.A manufacturing record review was completed , and no related non-conformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: TURNPIKE SPIRAL CE
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16543780
• Report Number: 2134812-2023-00013
• Device Sequence Number: 20455731
• Product Code: DQY
• UDI-Device Identifier: 10841156105082
• UDI-Public: 10841156105082
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 10/04/2023
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 713319
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: N/A.; N/A.
• Patient Age: 68 YR
• Patient Sex: Male