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

Catalog Number	H1-M
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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 a procedure to treat plaque in the proximal left superficial femoral artery using the hawkone m device, the device became stuck in a 6f non-medtronic (destination) sheath and could not be removed.Severe wire wrap and kinks in both the non-medtronic (boston sci platinum plus.014) wire and catheter were observed, resulting in the system being stuck in the sheath.Resistance was encountered when attempting to remove the system from the wire.After reviewing images and live fluoroscopy to assess device integrity and position, the system appeared intact with no detachment at that time.Multiple unsuccessful attempts were made to un-wrap the system.The physician was directed to remove the wire, system, and sheath together, which was performed successfully without vessel damage.After removal from the patient, several attempts were made to extract the hawk catheter from the sheath, and the device was eventually pulled out with extreme force, at which point nosecone detachment occurred outside the patient.No embolic protection was used, and the vessel was not pre- or post-dilated.The physician had made five passes with the device over a.014 non-medtronic (boston platinum plus) guidewire, rotating the torquer knob on each pass, which was believed to have contributed to the wire wrap.The intervention was aborted, and the procedure will be resumed in two weeks.No patient complications have been reported as a result of this event.
Event or Problem Description
(b)(6) 2025.
Additional Manufacturer Narrative
Image analysis the customer returned two images.Both images show the distal end of a hawkone device with the housing/tip detached.The detachment occurred distal to the anchor pockets.Product analysis the device was returned with its detached tip, a 0.014¿ guidewire and sheath.The proximal end of the handle is detached, and the device and 0.0142 guidewire are stuck in the sheath, a visual inspection found that the tip is detached distal to the anchor pockets, 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: 23606112
• Report Number: 9612164-2025-05758
• Device Sequence Number: 9917710
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: (01)00643169968332(17)280827(10)0012992938
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/12/2026

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-M
• Device Lot Number: 0012992938
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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: Male