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	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent directional atherectomy for chronic total occlusion (100% stenosis) of the left superficial femoral artery (mid and distal segments), characterized by 78mm moderate calcification and a fibrous lesion.The artery was 4.1-4.7mm in diameter.During the procedure, the atherectomy th plus 6f device was used following pre-dilation with a small balloon (3.0 mm diameter, 150 mm length).A 6fr non medtronic sheath and a 0.014 guidewire were used.A spider was used for embolic protection.After the first cut, the cutter could not be properly retracted into the collection chamber, and the thumb switch could not be returned to its normal position.The cutter remained unretractable regardless of the power status (on or off), and the collection chamber was not fully filled after the first cut.The physician followed the instructions for use, including pre-procedure flushing preparation, and no abnormalities were noted during flushing.Upon encountering the issue, the device was removed as a whole and flushed, but the cutter still could not be retracted.The device was replaced with a new turbohawk, and the procedure was completed successfully.No patient symptoms, complications, abnormalities, or injuries were reported during or after the procedure.No patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Image analysist he customer returned two video clips.The video clips show an atherectomy device.The operator is attempting to move the thumbswitch and is unable to do so.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: 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: 24648239
• Report Number: 9612164-2026-01432
• Device Sequence Number: 10207988
• Product Code: MCW
• UDI-Device Identifier: 00763000402396
• UDI-Public: (01)00763000402396(17)280929(10)0013050454
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: 0013050454
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 09/30/2025
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 62 KG