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

Model Number	5640
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found, therefore supporting the device met material, assembly and performance specifications.A returned product evaluation was completed and the failure was confirmed as the distal tip of the turnpike was separated.In addition, the damage found to the turnpike shaft and distal section is consistent with torqueing the catheter against resistance.The ifu warns, "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.".
Event or Problem Description
Physician was performing a pci angioplasty and atherectomy on a calcified lesion in the left distal circumflex.He was attempting to rotate our turnpike spiral through a tight distal lesion when the tip of the catheter broke off and was lodged into the lesion.The idea was to cross with the turnpike spiral and to switch out for the floppy rotowire to atherectomy the plaque.After the tip was lodged they aborted the atherectomy and performed an angioplasty.The tip remains in the patients distal left circ.And is resting in stable condition in the icu.The reason the patient was transferred to the unit was for observation to make certain the foreign body didn't migrate and the patient would bleed and become unstable.It is reported that the patient is in stable condition.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7949151
• Report Number: 2134812-2018-00070
• Device Sequence Number: 930912
• Product Code: DQY
• UDI-Device Identifier: M20656400
• UDI-Public: M20656400
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2018

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: 05/14/2020
• Device Model Number: 5640
• Device Lot Number: 625332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1