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

Catalog Number	H1-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
Additional Manufacturer Narrative
Continuation of d10: product type: 0676-directional atherectomy; implant date n/a; explant date n/a.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
It was reported that during treatment of a 100% stenosis due to plaque in the right superficial femoral artery (proximal and mid segments, lesion length 30cm, artery diameter 6mm, minimal tortuosity and calcification), the atherectomy h1-m hawkone m experienced a mechanical jam and the cutter driver/thumbswitch stopped functioning while in use in the patient.It was possible to turn off the thumbswitch. the cutter was positioned outside the housing at the time of the issue and during device removal, with no deformation noted in the cutter.This issue is reported for 2 hawkone m atherectomy devices.A 6fr non-medtronic sheath and a non-medtronic guidewire were used.The vessel was pre-dilated with a 3x150 nanocross percutaneous transluminal angioplasty balloon.The vessel was post-dilated.No resistance was encountered when advancing the devices. the devices were safely removed from the patient.The procedure was completed with percutaneous transluminal angioplasty. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Image analysis the customer returned two video clips for evaluation 2567: this clip depicts the hawk cutter driver device and the thumb switch is being switched on and off, the audio of the file indicates that the device is intermittently being operational.2570: this clip depicts a fluoroscopic image of the hawk device in the patients vasculature, the audio of the file indicates that the device is intermittently being operational.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: 24673380
• Report Number: 9612164-2026-01498
• Device Sequence Number: 13333528
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: (01)00643169968332(17)281023(10)0013097247
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/15/2026

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: 0013097247
• 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: 04/01/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 10/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRODUCT ID H1-M (0013144806),
• Patient Sex: Male