MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TURNPIKE LP 135CM; CATHETER

Catalog Number	5638
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
Dr.Was attempting to cross a tight lad lesion during atherectomy.He attempted crossing with a balloon and tpk lp 135.When trying to remove the turnpike, the tip broke off in the patient.They tried using pronto to suck it out- unsuccessfully.As of now, they have consulted with the surgeons and have decided to leave it in the patient for now.Patient is still in icu.They are ok as per cath lab manager.
Event or Problem Description
Dr.Was attempting to cross a tight lad lesion during atherectomy.He attempted crossing with a balloon and tpk lp 135.When trying to remove the turnpike, the tip broke off in the patient.They tried using pronto to suck it out- unsuccessfully.As of now, they have consulted with the surgeons and have decided to leave it in the patient for now.Patient is still in icu.They are ok as per cath lab manager.
Additional Manufacturer Narrative
(b)(4).No returned product evaluation could be completed as there was no product returned for this complaint.The customer shared picture was reviewed which identified distal tip material of approximately 3mm was missing.Liner at the distal end was exposed.A video of the angiogram was shared.Tip material was observed to be lodged in the vessel.A dhr review was completed for lot 73m2200340.No issues or nonconformities noted.Case details were reviewed.Customer stated," dr.Was attempting to cross a tight lad lesion.He used rota blade for atherectomy.Then attempted crossing with a balloon and tpk lp 135.When trying to remove the turnpike, the tip broke off in the patient.They tried using pronto to suck it out- unsuccessfully.As of now, they have consulted with the surgeons and have decided to leave it in the patient for now.Patient is still in icu and ok per him''.As per the additional information received, the turnpike tip was trapped mid lad lesion.The tip was left in the lesion.The tip could not be retrieved.Procedure was aborted and open-heart cabg was performed.Patient condition is stable.It is likely that the tip was damaged when operated against re sistance against a calcified lesion.The ifu along with the product 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.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking.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.Excessive rotation with the tip stuck could lead to tip material separation.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.The der process will continue to monitor for any similar events.

• Brand Name: TURNPIKE LP 135CM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18524282
• Report Number: 2134812-2024-00001
• Device Sequence Number: 12793449
• Product Code: DQY
• UDI-Device Identifier: 10841156100681
• UDI-Public: 10841156100681
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: 12/13/2024
• Device Catalogue Number: 5638
• Device Lot Number: 73M2200340
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/21/2024
• 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.
• Patient Sex: Unknown