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

Catalog Number	THP-M
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
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
Physician attempted to use a turbohawk plus atherectomy device for patient treatment in the popliteal artery.No abnormalities reported in relation to anatomy.A non-medtronic sheath (7f cook) was used.Ifu was followed.It is reported that when the product was passed through the guidewire outside the patient's body, there was obvious resistance, and the guidewire could not pass through the inside of the product.During the percutaneous puncture antegrade popliteal artery opening surgery, the surgeon used the disposable peripheral plaque removal device, the product needed to pass through the guide wire to reach the lesion site, however, in the process of passing the guide wire through the product, encountered obvious resistance, resulting in the guide wire unable to pass through in the product.Then, the surgeon replaced it with another surgical device, using ordinary balloons and drug-coated balloons for combined treatment to complete the operation.There was a break between the blade and the wire that drove the blade.The surgery was continued by replacing with another device and with the cooperation of spider fx to complete the surgery successfully.No patient injury reported.
Additional Manufacturer Narrative
Product analysis the device was returned without its cutter driver.A cutter driver from the lab was attached and the thumbswitch was found to be positioned in the ¿on¿ position.A visual inspection could find no issue with the housing/tip and a 0.014¿ guidewire was loaded without issue, the cutter was positioned in the cutter window, the thumbswitch was advanced and the cutter advanced approximately 26mm into the housing, the thumbswitch was retracted and the cutter returned to the cutter window and rotated, the thumbswitch and cutter could be retracted and advanced without issue.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: 21136682
• Report Number: 9612164-2025-00224
• Device Sequence Number: 15159767
• Product Code: MCW
• UDI-Device Identifier: 00763000402396
• UDI-Public: 00763000402396
• 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): 03/06/2025

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: THP-M
• Device Lot Number: 0012250063
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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