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

Model Number	5640
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/02/2023
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: the physician found the product failed to advance the calcified legion during pci so while the physician was removing the catheter back, the tip got splited and stuck in the patient s blood vessel.Additional information on 16feb2023, during a pci procedure on the (b)(6) 2023, the above incident occurred, the customer reported that the defect may have occurred because of unintentional error and no issue with the product.The patient was reported as fine post procedure.Additional information has been requested from the account and will be added to the follow up report on receipt.
Additional Manufacturer Narrative
Qn#(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.The top-level assembly traveler was reviewed.There are no dda's, nce's or any other non-conformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.A patient underwent a pci procedure.A turnpike spiral was used in the case.Physician found the product failed to advance via the calcified lesion.Tip was split when attempting to remove it.Tip was stuck in the vessel.No product was returned for evaluation.It is unknown if any other shaft or torque damages were noted on the unit.The damages are likely to have occurred during use in the procedure 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.More rotations were employed in a trapped state.The tip was removed with a snare.Another microcatheter was used to complete the procedure.No angiograms or images were shared.No patient harm was noted.Customer stated that defect occurred because of unintentional error and no issue with the product.Based on the information, it is likely that the unit was torqued in a trapped state leading to tip fatigue and breakage.A manufacturing record review was completed and no related non-conformances were found.Based on the information and no product evaluation, 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 physician found the product failed to advance the calcified legion during pci so while the physician was removing the catheter back, the tip got split and stuck in the patient s blood vessel.Additional information on (b)(6) 2023, during a pci procedure on the (b)(6) 2023, the above incident occurred, the customer reported that the defect may have occurred because of unintentional error and no issue with the product.The patient was reported as fine post procedure.Additional information has been requested from the account and will be added to the follow up report on receipt.

• Brand Name: TURNPIKE SPIRAL
• 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: angela meister ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16425990
• Report Number: 2134812-2023-00005
• Device Sequence Number: 15202097
• Product Code: DQY
• UDI-Device Identifier: 10841156105082
• UDI-Public: 10841156105082
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 716462
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 04/05/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown