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

Catalog Number	TH-LX-M
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a directed resection procedure using the turbohawk device for treatment of a right mid superficial femoral artery lesion with 70% stenosis, moderate calcification, and fibrous and calcified plaque, several device issues occurred.Preoperative preparation was performed according to instructions, including pre-dilation with a 3.0 millimeter balloon.During the first insertion, the cutting head was advanced through the lesion and then withdrawn for cutting from the proximal to distal end.Upon reaching the distal end and attempting to retrieve the cutting head, the thumb switch could not be pushed normally.The surgeon turned off the handle switch and attempted multiple times to push and retrieve, but the switch could not be closed properly, resulting in a procedural delay.The entire device was removed from the patient, and it was found that the proximal collection chamber of the cutting head had been damaged by the cutting head itself, the cutter was damaged, and the flush port on the catheter handle was also damaged.The damaged cutter required retrieval from the patient by removing the entire device.The surgeon replaced the device with the same model and continued the procedure in other directions.Post-dilation was performed, and the surgery was completed successfully.No patient complications have been reported as a result of this event.Additional information 2025-oct-17: the device was safely removed from the patient and no intervention was required for the removal of the device.
Additional Manufacturer Narrative
Product analysis: device was decontaminated with cidex opa solution soak and tergazyme soak.A visual inspection showed that the tip detached at the cutter window.The detached component was not returned.Image analysis: the customer returned two images and one video clip.The images show the tip/housing of the device still attached to the torque shaft.There is visible damage at the cutter window.The video clip shows the tip/housing of the device still attached to the torque shaft.The tip/housing is being moved and there is visible damage at the cutter window.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ATK TURBOHAWK SMOOTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23477371
• Report Number: 9612164-2025-05437
• Device Sequence Number: 10228685
• Product Code: MCW
• UDI-Device Identifier: 00763000918934
• UDI-Public: (01)00763000918934(17)280523(10)0012834320(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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 Catalogue Number: TH-LX-M
• Device Lot Number: 0012834320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 69 KG