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

Model Number	5642
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One unit was returned to vsi for evaluation.The catheter shaft was severely damaged.The distal tip section was separated and not returned with the catheter.Ptfe liner and braid were exposed at the point of separation on the distal end of the catheter.All the damage is consistent with continuous torquing in one direction with the tip being fixed.A manufacturing record review was complete and there were no non-conformances related to this lot therefore supporting the device met material, assembly and performance specifications prior to shipment.The turnpike ifu warns; 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 or turnpike lp, unwind the catheter to its relaxed position and apply backward tension to dislodge the tip.
Event or Problem Description
Patient was received in the cath lab with arrythmia-vt and chest pain.Physician attempted to open an lad lesion that was suspected to be heavy calcified and a complex case.The physician met resistance in the vessel right away but kept torquing the catheter without releasing.Physician realized the catheter wasn't advancing anymore and tried to remove the guidewire with the turnpike catheter, when a small piece of the tip of the catheter detached from the wire.The physician didn't snare or try to remove the piece of the tip.The turnpike catheter was successfully retrieved.They cancelled the intervention.Physician and staff informed me the patient is doing well and did not have a major adverse event.The physician stated, the family of turnpike catheters probably wasn't the right catheter for that specific lesion.Additional information received 11mar19: the tip of the turnpike detached, and the guidewire was fine after it was retrieved.The physician didn't perform any procedures to remove the piece of the tip of the catheter left behind in the artery, and the tip is in the mid distal lad vessel.The patient is stable post procedure and no further interventions were required.Anticoagulants have been prescribed.

• Brand Name: TURNPIKE SMOOTH
• Common Device Name: CATHETER,
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8472746
• Report Number: 2134812-2019-00015
• Device Sequence Number: 1846895
• Product Code: DQY
• UDI-Device Identifier: M20656420
• UDI-Public: M20656420
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/06/2019

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: 11/05/2020
• Device Model Number: 5642
• Device Lot Number: 636864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/02/2019
• 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: Other
• Patient Age: 86 YR
• Patient Weight: 113