MAUDE Adverse Event Report: MEDTRONIC IRELAND TURBOHAWK PLUS 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	THP-M
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
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 treatment of a calcified lesion in the right superficial femoral and popliteal arteries (mid and distal segments, 60-80% stenosis, 150mm length, 4-6mm diameter, moderate calcification, minimal tortuosity) with the atherectomy th plus 6f device, a mechanical jam occurred.A 6fr non-medtronic (terumo) sheath and a 5mm spider fx embolic protection device/guidewire were used.No resistance was encountered during device advancement.The vessel was post-dilated with an ipu05015013p inpact admiral dcb balloon.The instructions for use were followed without issue.It was reported that the thumbswitch could not be turned off.No deformation was noticed in the cutter.The cutter was positioned outside the housing during device removal from the patient.The device was safely removed from the patient.The procedure was completed using a new turbohawk plus atherectomy device.No patient complications have been reported as a result of this event.

• Brand Name: TURBOHAWK PLUS 6FR
• 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: 24589009
• Report Number: 9612164-2026-01316
• Device Sequence Number: 12193663
• Product Code: MCW
• UDI-Device Identifier: 00763000402396
• UDI-Public: (01)00763000402396(17)281109(10)0013126184
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: THP-M
• Device Lot Number: 0013126184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Date Device Manufactured: 11/10/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male