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	08/22/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported by the director at (b)(6) hospital, that during a cto lad lesion surgery: "lad was very tight.Could not pass 1.5mm balloon so tried to advance a turnpike through the lesion.It's believed that the turnpike tip movement was constricted, and the turnpike continued to be rotated more than 2 full 360 degree rotations.Approx.2-3 mm of the turnpike tip broke off in the patient.After the tip broke off, i was told a stingray was used to go subintimal, and at some point, after that the patient started to decline.The separated tip occluded flow down the lad leading to st elevations on telemetry and significant patient pain.The patient went into cardiogenic shock and ventricular fibrillation about 1-2 hours later.Offered surgery, but patient's family was adamant that she did not want surgery.Were unable to remove the device as it was lodged in the lad lesion.Were not able to wire around the device.Tried dissection and re-entry around the lesion but was unsuccessful.Cause of death: ventricular fibrillation, myocardial infarction." additional information quoted: cardiovascular lab notes supplied by (b)(6) hospital to (b)(6): "the patient was brought to the lab for a known high-risk pci involving the left main coronary artery.Diagnostics taken at the beginning of the case brought to light a tight lesion in the mid left anterior descending artery.Attempts to use angioplasty ballooning failed to open the lesion enough to pass a stent.A turnpike microcatheter was selected to help advance and open the lesion.While using the microcatheter, a 1 cm portion of the catheter tip embolized and was lodged in the lad resulting in no blood flow distal.The doctor emergently consulted his colleague to evaluate potential for bypass options.The doctor also consulted with family and communicated the likelihood of a poor outcome without surgery.The family stated it was the patient's wish to not have cabg performed.Attempts at rewiring and dislodging eventually led to the use of a microcatheter to form a new passageway for blood flow.An unintended dissection plane rapidly formed proximally until it was presumed moving into the ascending aorta.Multiple vasopressors and defibrillations were started and delivered to try and stabilize the patient, but the patient rapidly declined and was unable to be resuscitated.".
Additional Manufacturer Narrative
(b)(4).One-unit of turnpike was returned for evaluation.Blood particulates were noted.Unit was decontaminated and inspected.Approximately 0.4 cm of tip material was missing.The remaining tip material present was fatigued.A dhr review was completed lot 73a2300139 and no issues or nonconformities were noted.Case details were reviewed.A patient (female, 74y) underwent a pci (percutaneous coronary intervention) high risk procedure for cto (chronic total occlusion) of lad (left anterior descending).Damages observed on the tip is indicative of the material subjected to resistance.This is likely to have occurred when the tip was continued to be rotated when lodged within the lesion.The additional information received indicates that lesion was tight at mid lad.Ballooning failed to open the lesion.Turnpike was used to open the lesion.1 cm of the tip embolized and was lodged in the lad.Two full rotations were continued to be performed with constricted tip movement.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 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.Tip was lodged in the lesion leading to no blood flow downstream.This led to st elevation.Cabg (coronary artery bypass graft) options were evaluated and declined by patients' family.Attempts at rewiring and dislodging eventually led to the use of a stingray microcatheter to form a new passageway for blood flow.An unintended dissection plane rapidly formed proximally until it was presumed moving into the ascending aorta.Multiple vasopressors and defibrillations were started and delivered to try and stabilize the patient, but the patient rapidly declined and was unable to be resuscitated.No angiograms or fluoroscopic pictures were provided.The reported cause of death was ventricular fibrillation and myocardial infarction.Medical history includes significant multi vessel cad (coronary artery disease) and recent stroke.Based on the information, the most likely root cause of the issue is user error.
Event or Problem Description
It was reported by the director at (b)(6) hospital, that during a cto lad lesion surgery: "lad was very tight.Could not pass 1.5mm balloon so tried to advance a turnpike through the lesion.It's believed that the turnpike tip movement was constricted, and the turnpike continued to be rotated more than 2 full 360 degree rotations.Approx.2-3 mm of the turnpike tip broke off in the patient.After the tip broke off, i was told a stingray was used to go subintimal, and at some point, after that the patient started to decline.The separated tip occluded flow down the lad leading to st elevations on telemetry and significant patient pain.The patient went into cardiogenic shock and ventricular fibrillation about 1-2 hours later.Offered surgery, but patient's family was adamant that she did not want surgery.Were unable to remove the device as it was lodged in the lad lesion.Were not able to wire around the device.Tried dissection and re-entry around the lesion but was unsuccessful.Cause of death: ventricular fibrillation, myocardial infarction." additional information quoted: cardiovascular lab notes supplied by (b)(6) hospital to teleflex: "the patient was brought to the lab for a known high-risk pci involving the left main coronary artery.Diagnostics taken at the beginning of the case brought to light a tight lesion in the mid left anterior descending artery.Attempts to use angioplasty ballooning failed to open the lesion enough to pass a stent.A turnpike microcatheter was selected to help advance and open the lesion.While using the microcatheter, a 1 cm portion of the catheter tip embolized and was lodged in the lad resulting in no blood flow distal.The doctor emergently consulted his colleague to evaluate potential for bypass options.The doctor also consulted with family and communicated the likelihood of a poor outcome without surgery.The family stated it was the patient's wish to not have cabg performed.Attempts at rewiring and dislodging eventually led to the use of a microcatheter to form a new passageway for blood flow.An unintended dissection plane rapidly formed proximally until it was presumed moving into the ascending aorta.Multiple vasopressors and defibrillations were started and delivered to try and stabilize the patient, but the patient rapidly declined and was unable to be resuscitated.".

• 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: 20234565
• Report Number: 2134812-2024-00049
• Device Sequence Number: 18183365
• Product Code: DQY
• UDI-Device Identifier: 10841156108755
• UDI-Public: (01)10841156108755(11)230215(17)250103(10)73A2300139(21)
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/22/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2025
• Device Catalogue Number: 5640
• Device Lot Number: 73A2300139
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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: N/A.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 88 KG