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	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during atherectomy of a calcified, 100% stenosed target lesion in the proximal left posterior tibial artery with a vessel diameter of 5.0 mm, the hawkone h1-m device thumb switch would not move to the off position after cutting, including after removal from the body.Embolic protection was used with a spider 4.0 device, the vessel was pre-dilated with a nanocross 3 x 120 device, and post-dilated with an in.Pact 5 x 250 device.The hawkone h1-m device was safely removed from the patient.The procedure was completed using a new hawkone ls device.The event delayed surgery by 10 minutes.No patient complications have been reported as a result of this event.Additional information: when the device was returned for evaluation the cutter was detached/broken from the driveshaft.
Additional Manufacturer Narrative
Product analysis: the device was returned with the thumbswitch in the ¿on¿ position, and the cutter positioned in the cutter window.The thumbswitch was advanced but the thumbswitch and the cutter would not move.The housing was removed at the hinge pins, and a visual inspection found the that the cutter was detached/broken from the driveshaft.The detached cutter remains inside the housing.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 ; +353(091)708096
• MDR Report Key: 50850904
• Report Number: 9612164-2026-04752
• Device Sequence Number: 9923308
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 09/22/2026

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: 0013371731
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2026
• 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