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

Model Number	5642
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned for this complaint so there was no product evaluation completed.A manufacturing record review was completed and no related nonconformances were found.The event details state that the device was pulled against resistance after it became stuck on an existing stent strut.The turnpike 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." the root cause for the separation is related to operational context and user error.
Event or Problem Description
The turnpike was used tor a complex pci involving the circ and lad.A wire was advance across a stent strut and followed by the turnpike catheter.Upon removal of the turnpike, it got stuck on the stent and when it was pulled back with resistance a small piece of the turnpike tip broke off and remained in the vessel.The physician felt resistance at stent strut, he tried to spin, though would not cross.Tip broke on pullback.The physician stated, that he thinks the wire was behind the stent and the turnpike got stuck because of that.The piece of the turnpike was jailed between the lumen and stent.The patient tolerated the procedure well and is doing great.No patient harm done.There is no plan to remove the "piece" of the turnpike.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9590748
• Report Number: 2134812-2020-00001
• Device Sequence Number: 667384
• Product Code: DQY
• UDI-Device Identifier: 30841156100722
• UDI-Public: (01)30841156100722
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/17/2019

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: 09/13/2021
• Device Model Number: 5642
• Device Lot Number: 657715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR