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

Catalog Number	H1-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	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the end of the clean out device blew off during saline aspiration while flushing for cleanout of packing storage of the atherectomy h1-m hawkone m device.The patient was being treated for plaque in the left proximal, mid, distal superficial femoral artery and popliteal artery.Artery diameter reported as 3-5 mm.A 6fr non-medtronic (terumo destination) sheath and a 5mm spider fx embolic protection device were used.The vessel was pre-dilated with a 3x200 non-medtronic (boston scientific sterling) balloon.The vessel was post-dilated with an ipu05015013p in.Pact 018 drug coated balloon.The device was safely removed from the patient, and the procedure was completed using a new h1-m device.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
Product analysis the device was returned with the thumbswitch approximately halfway between the ¿on¿ and ¿off¿ positions, and with the distal flush tool (dft) positioned over the housing, the dft was retracted and no issue was found with the housing or tip, the cutter was positioned approximately 6mm inside the housing, the thumbswitch was then fully retracted and the cutter returned to the cutter window and rotated, the thumbswitch was then fully advanced and the cutter advanced approximately 28mm into the housing, there was no issue with advancing and retracting the thumbswitch and cutter and no issues were found with the device.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: HAWKONE 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: 24055737
• Report Number: 9612164-2026-00207
• Device Sequence Number: 21268633
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: (01)00643169968332(17)281005(10)0013061362
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K161361
• 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): 02/05/2026

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: H1-M
• Device Lot Number: 0013061362
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• 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: Female