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

Model Number	5642
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Reduced Blood Flow (4598)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(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: we had an issue yesterday with a turnpike tip fracturing in the patients diag artery.When it was finally retrieved, it was bound to the wire.Additional information: the above issue occurred during a pci procedure on the (b)(6) 2023, the patient suffered a disruption of the lad & impaired flow to the lad per md's note.To fix this, md needed to stent lad and diagonal.The turnpike was removed in its entirety.The patient's vessels were described as calcified.Post procedure the patient's condition was reported as stable, they were sent to icu, then discharged home from there.
Additional Manufacturer Narrative
(b)(4).One-unit of turnpike was returned to vsi/teleflex for evaluation.Blood particulates were noted on the unit.The distal of the turnpike was observed to be fatigued and separated.The separated tip material was lodged into the shaft of the guidewire.Unit was manufactured at tecate.A dhr review was completed.No nonconformances noted.Case details were reviewed.Customer stated that the turnpike into the patient's diagonal artery.One-unit of turnpike was returned to vsi/teleflex for evaluation.Blood particulates were noted on the unit.The distal of the turnpike was observed to be fatigued and separated.The separated tip material was lodged into the shaft of the guidewire.The damages are likely to have occurred during use in the procedure when operated against a calcified lesion.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.A response was received.Vessel was calcified.Turnpike was trapped in the lesion.The user successfully removed the turnpike with the separated material bound to the guidewire.No other micro catheter was used.Disrupted flow to the lad was noted by the physician.A stent to the lad and diagonal branch was placed.It is likely due to excessive rotation and torque against a calcified lesion, tip material is likely to have separated.Patient is stable.A manufacturing record review was completed by tecate and no related nonconformances were found.Based on the information, the most likely root cause of the issue is user error.
Event or Problem Description
It was reported that: we had an issue yesterday with a turnpike tip fracturing in the patients diag artery.When it was finally retrieved , it was bound to the wire.Additional information: the above issue occurred during a pci procedure on the (b)(6) 2023, the patient suffered a disruption of the lad & impaired flow to the lad per md's note.To fix this, md needed to stent lad and diagonal.The turnpike was removed in its entirety.The patient's vessels were described as calcified.Post procedure the patient's condition was reported as stable, they were sent to icu, then discharged home from there.

• Brand Name: TURNPIKE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton MN 19341
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16884404
• Report Number: 2134812-2023-00017
• Device Sequence Number: 6140357
• Product Code: DQY
• UDI-Device Identifier: 10841156108779
• UDI-Public: 10841156108779
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 06/21/2024
• Device Model Number: 5642
• Device Catalogue Number: 5642
• Device Lot Number: 73F2200754
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/13/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 96 KG