MAUDE Adverse Event Report: MEDTRONIC IRELAND ATK TURBOHAWK SMOOTH; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	TH-LX-M
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A physician was attempting to use a turbohawk atherectomy to treat a severely calcified little tortuous lesion in the left mid superficial femoral artery (sfa) presenting with 90% stenosis.Artery diameter is 6mm, and lesion length 190mm.The device was prepped with no issue.Device prepped per ifu.It was reported that the device was jammed/will not close. the turbohawk device would not close after several passes.The device stopped functioning while in use in the patient.The cutter crashed outside the housing.The physician removed the device and used a different turbohawk device successfully.The physician was able to turn off the thumbswitch.During removal of the device from the patient the cutter was located outside the housing.The device was safely removed from the patient with no deformation noted in the cutter.No patient injury reported.

• Brand Name: ATK TURBOHAWK SMOOTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12358139
• Report Number: 9612164-2021-03259
• Device Sequence Number: 3794306
• Product Code: MCW
• UDI-Device Identifier: 00643169968424
• UDI-Public: 00643169968424
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2024
• Device Model Number: TH-LX-M
• Device Catalogue Number: TH-LX-M
• Device Lot Number: 0010633181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1