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

Model Number	5638
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the tip of turnpike separated onto wire.Wire would not come out of guide.Guide and wire removed together.Tip of turnpike lp remains on wire.Additional information reported on 11nov2022: the entire turnpike and tip were removed from the vessel after tip separation.The physician then completed the procedure.The patient coded in recovery.Date of death (b)(6) 2022.There were no issues in the lab with the patient as far as hemodynamics, pain, etc.The physician reported that he does not believe the tip separation had anything to do with the expiration of the patient.
Additional Manufacturer Narrative
(b)(4).One-unit of turnpike lp was returned for evaluation.Blood particulates were noted on the unit.Tip material was observed to be separated and lodged on the guidewire.The guidewire spring-coil was observed to be torqued, damaged, and deformed from its original shape.A device history record review was requested.No issues or nonconformance's noted.Reported case details were reviewed: patient underwent a pci procedure in which a turnpike lp was used; the tip of the turnpike lp separated onto the guidewire, which would not come out of guide catheter; the guide catheter and guidewire were removed together; and the tip of the turnpike lp remained on the guidewire.One-unit of turnpike lp was returned for evaluation.Blood particulates were noted on the unit.Tip material was observed to be separated and lodged on the guidewire.The guidewire spring-coil was observed to be torqued, damaged, and deformed.Damages are likely to have occurred during use in the procedure along with guidewire when operated against resistance.Per ifu, the following warning and precautions were noted: 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.In response to a request for additional information, it was further reported: case was not a cto.The turnpike lp was used per ifu.The entire turnpike lp and tip were removed from the vessel.Turnpike spiral 135cm was used after the turnpike lp.The physician completed procedure after tip separation.Angiogram images were sent by the customer without any notes or information.Sequence of events is unclear from angiogram images.The account confirmed the physician did not capture tip separation in angiogram images.It is likely due to the interaction of the guidewire and turnpike lp tip material against the lesion when operated against resistance could have caused the separation and lodging of the material with the guidewire shaft.It was reported that the patient was deceased post procedure.Physician stated that the turnpike lp did not contribute to the death, and tip separation had nothing do with the expiration of the patient.It was also reported there were no issues in the lab with the patient as far as hemodynamics, pain, etc.The reported cause of death is unknown.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 that: the tip of turnpike separated onto wire.Wire would not come out of guide.Guide and wire removed together.Tip of turnpike lp remains on wire.Additional information reported on 11nov2022: the entire turnpike and tip were removed from the vessel after tip separation.The physician then completed the procedure.The patient coded in recovery.Date of death on (b)(6) 2022.There were no issues in the lab with the patient as far as hemodynamics, pain, etc.The physician reported that he does not believe the tip separation had anything to do with the expiration of the patient.

• Brand Name: TURNPIKE LP
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: angela meister ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15924584
• Report Number: 2134812-2022-00058
• Device Sequence Number: 14753027
• Product Code: DQY
• UDI-Device Identifier: 10841156108731
• UDI-Public: 10841156108731
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K191560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/08/2022

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 Model Number: 5638
• Device Catalogue Number: 5638
• Device Lot Number: 73E2201176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/06/2023
• 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.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male