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

Model Number	THP-M
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	10/04/2024
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
A turbohawk plus was being used for treatment of the superficial femoral artery.A spider fx was used for embolic protection.The vessel was pre and post-dilated.There was no resistance during advancement and the device did not pass through a previously deployed stent.The ifu was followed.The device was safely removed from the patient.It was reported during cleaning pos use, the tip detached.The guidewire lumen was not torn/ripped.The guidewire did not prolapse leading to tip detachment.No patient injury.
Additional Manufacturer Narrative
Product analysis: the device was returned with the distal flush tool (dft) positioned over the distal end of the device.A visual inspection showed that the tip detached from the housing distal to the anchor pockets.The detached tip was not returned.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: 20408254
• Report Number: 9612164-2024-04609
• Device Sequence Number: 14297649
• Product Code: MCW
• UDI-Device Identifier: 00763000402396
• UDI-Public: 00763000402396
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 12/19/2024

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 Model Number: THP-M
• Device Catalogue Number: THP-M
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/19/2024
• Date Device Manufactured: 05/30/2024
• 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 Sex: Unknown