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

Model Number	5640
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of device history records will be conducted.A follow-up report will be issued after the investigaiton is complete.
Event or Problem Description
The turnpike spiral distal tip got caught in a calcified channel on the median rca and detached from the body of the catheter.It stayed fixed in the occlusion and did not migrate.The occlusion could not be opened.No consequence for the patient.The physician decided to abort the case as the vessel was to densely and hardily calcified.Additional information on (b)(6) 2022: tried to snare it out, but they could not as the distal tip was completely stuck in the occlusion.It was stuck in the proximal calcium cap.The case was stopped as the lesion was impenetrable and retrograde access was not possible.Patient was stable.No complications for the patient.Medical management of the patient's symptoms will be continued and no other procedure is planned at this time.
Additional Manufacturer Narrative
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 nonconformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.A patient underwent a procedure for a cto of the rca.A turnpike spiral was used in the case.The tip got stuck in the calcified channel and detached from the body of the catheter.It is unknown if any other damages could have occurred along the shaft of the catheter, and how much of the tip was separated.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.It is likely that the turnpike spiral was operated against resistance and/or against a calcified vessel that could have led to the tip incurring damages.Subsequently, leading it to break off within the artery.Subsequently, leading it to break off within the artery.Additional information was requested.A response was received.Physician attempted to snare the tip but was unsuccessful.Tip was completely stuck in proximal calcium cap and did not migrate.Retrograde access was not possible.It is unknown how many rotations were made with the tip being intact in the vessel.It is unknown to what extent, degree, or rigor this device has seen use and handling.No pictures or angiograms of the issue were shared.The case was stopped.No complications noted for the patient.Based on the information, the most likely root cause is undeterminable.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564300
• MDR Report Key: 14844729
• Report Number: 2134812-2022-00037
• Device Sequence Number: 14638609
• Product Code: DQY
• UDI-Device Identifier: 10841156105082
• UDI-Public: 10841156105082
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K212211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/08/2022

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: 02/10/2024
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 715935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: Required Intervention
• Patient Sex: Male