MAUDE Adverse Event Report: MEDTRONIC IRELAND TURBOHAWK PLUS 7FR; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	THP-LX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a turbohawk plus atherectomy device for patient treatment in the left prox/mid superficial femoral artery with calcification (cto).No abnormalities reported in relation to anatomy.A non-medtronic sheath (7f cook) was used.Ifu was followed.Vessel was predilated.It is reported that tip detached / tip damage occurred.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
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
Product analysis the device was returned with the thumbswitch positioned in the ¿off¿ 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guidewire was loaded without issue, the cutter was positioned approximately 29mm inside the housing, the thumbswitch was retracted fully and the cutter returned to the cutter window and rotated the thumbswitch was advanced and the cutter advanced approximately 29mm into the housing, the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 7FR
• 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: 21111333
• Report Number: 9612164-2025-00165
• Device Sequence Number: 21003171
• Product Code: MCW
• UDI-Device Identifier: 00763000402358
• UDI-Public: 00763000402358
• 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-LX
• Device Lot Number: 0012414827
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: 65 YR
• Patient Sex: Female