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

Model Number	TH-LX-M
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the turbohawk was returned coiled inside the product shelf carton.The cutter driver did not return for analysis.No ancillary devices were returned.The preliminary inspection found the distal assembly was separated at the hinge.Tip assembly was clearly separated at the hinge and the cutter is visible inside the cutter window.No damage noted to the platinum iridium coil portion of the tip assembly.Both hinge pins are visible inside the proximal end of the housing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a turbohawk device with a non-medtronic 7fr sheath and 6mm spider fx during treatment of a soft plaque lesion in the mid superficial femoral artery (sfa).The lesion was soft plaque.Ifu was followed.It is reported that treatment with the device was complete but during removal the packing tube detached from the catheter inside the sheath.The entire collection chamber did not detach from the device.The detachment occurred within the sheath.Moderate resistance was noted during device removal.No intervention was required and all device components were accounted for.A second turbohawk was not needed as the procedure was already completed.There was no issues noted with the spider fx.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: 11581768
• Report Number: 9612164-2021-01215
• Device Sequence Number: 20029121
• 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): 03/29/2021

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: 05/26/2022
• Device Model Number: TH-LX-M
• Device Catalogue Number: TH-LX-M
• Device Lot Number: 0009758182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1