MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-LX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
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
It was reported that during treatment of a calcified peripheral artery lesion in the right mid superficial femoral artery using the hawkone device, the thumb switch stopped working after two passes in a hard calcified lesion and a mechanical jam was reported.The device was initially used in a softer lesion in the common femoral artery without issue.The target lesion was described as minimally calcified with 60% stenosis, 40 mm lesion length, and 6 mm vessel diameter.Embolic protection was used with a spiderfx device, and the device was used with a 7fr non-medtronic sheath and a 014 spiderfx wire.The vessel was not pre-dilated and was post-dilated using a chocolate and an 018 drug coated balloon.It was reported that it was not possible to turn off the thumb switch, no resistance was encountered when advancing the device, and no cutter deformation was noticed.During device removal, the cutter position was reported as outside the housing, and the device was safely removed.The procedure was completed using a new h1-lx device.No health consequences or impact were reported.
Additional Manufacturer Narrative
Product analysis the device was returned without its cutterdriver, a cutterdriver from the lab was attached and it was found that the thumbswitch was in the ¿off¿ position, and the cutter was positioned approximately 27mm 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.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 7F
• 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: 24843806
• Report Number: 9612164-2026-01859
• Device Sequence Number: 12178353
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: (01)00643169968509(17)281216(10)0013197225
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• 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): 06/12/2026

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-LX
• Device Lot Number: 0013197225
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Male