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 In Patient (2687)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: pci (non cto), tip of catheter lodged in artery (circ) and unable to be removed.Incident occurred during the procedure, inside the patient.Clinical consequences: patient stable no - st changes, no chest pain.The device was removed and the procedure was halted.Physician may have over torqued the device.
Additional Manufacturer Narrative
A follow-up report will be issued after the investigaiton is complete.
Additional Manufacturer Narrative
Turnpike spiral was returned to for evaluation.Blood particulates were noted on the catheter.The tip was chewed and fatigued.The tip measured approximately 1.1cm.No significant material missing.No other shaft damages were observed.The device history records were reviewed.There are no non conformance's related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.Patient underwent a pci procedure.A turnpike spiral was used in the procedure.Physician stated that the tip of turnpike spiral was lodged inside the artery and was unable to be removed.The damages are likely to have occurred during use in the procedure against a calcified vessel.Per ifu, states the following warnings 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 becomes lodged and is not also rotating, as it may result in separation of the catheter, damage to the catheter, or vessel injury.If using the turnpike spiral, rotate the catheter in the counterclockwise direction with backward tension in order to dislodge the tip.- 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.Account stated that the catheter may have been over rotated with more than two consecutive 360 degree rotations when the distal tip was trapped.No medical intervention was done.The procedure was aborted due to this event.Device was removed.Patient was stable without any issues.Based on the information, the most likely root cause of the issue is user error.

• 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: 12980234
• Report Number: 2134812-2021-00075
• Device Sequence Number: 4715093
• Product Code: DQY
• UDI-Device Identifier: 10841156105082
• UDI-Public: 10841156105082
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191560
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 12/22/2022
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 705084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• 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: Unknown