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

Catalog Number	H1-S
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis a visual inspection found the that the cutter was detached 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a procedure to treat a 75% stenosis, 150 mm lesion in the proximal right tibial/popliteal trunk, the hawkone s cutter driver would not close and subsequently stopped functioning while in use in the patient.The device was safely removed from the body with no difficulty, and a new h1-s device was used to successfully complete the procedure.Additionally, the rapidcross balloon was found to have a cracked hub, inflation difficulties, and a leak at the hub/leur during preparation; this device was not used in the patient.A new rapidcross device was used to complete the procedure.The instructions for use were followed during preparation and procedure.No resistance was encountered when advancing the devices, and there were no issues with packaging or device removal from the tray.Embolic protection was used with a spider filter wire, and a 7 french terumo destination sheath was utilized.The vessel was post-dilated using the rapidcross device.The patient remained alive with no injury.No patient complications have been reported as a result of this event.When the device was returned for evaluation, it was noted that the cutter was detached.

• 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: 25444481
• Report Number: 9612164-2026-02977
• Device Sequence Number: 12194381
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: (01)00643169968356(17)281021(10)0013092669
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/09/2026

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-S
• Device Lot Number: 0013092669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• 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: Unknown