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

Model Number	5640
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One-unit model 5640 turnpike spiral was returned for evaluation along with a guidewire that was used in the procedure.The distal tip of the turnpike spiral was severely damaged with about 2mm of tip material separated.The damage on the tip was consistent with over torquing the catheter in a calcified lesion.The separated material remained on the returned guidewire.The guidewire was also damaged with the outer coil broken, causing the tip material to become caught in the coils.The turnpike spiral 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 passing a wire down a calcified lad during a pci.He was using a wire and a turnpike spiral.When he was attempting to maneuver the turnpike spiral it was difficult since it was a cto, and a little resistance was felt.During advancement of the wire, it was buckling back.However, the wire motion was free in the turnpike throughout the procedure.He then moved the turnpike spiral back out of the vessel and noticed that the tip remained within the lad.The tip and the device were removed successfully from the patient through a 7fr guideliner.Outcome of the patient was a successful pci.There was no patient injury reported in this case.

• Brand Name: TURNPIKE SPIRAL
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9262358
• Report Number: 2134812-2019-00072
• Device Sequence Number: 11703023
• Product Code: DQY
• UDI-Device Identifier: 10841156100704
• UDI-Public: (01)10841156100704
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K151981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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: 06/13/2021
• Device Model Number: 5640
• Device Catalogue Number: 5640
• Device Lot Number: 651081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/31/2019
• 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