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

Catalog Number	H1-S
Medical Device Problem Codes	Entrapment of Device (1212); Device Difficult to Setup or Prepare (1487); Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an hawkone s was used during a peripheral artery procedure involving the left proximal superficial femoral artery with a calcified, fibrous, plaque, and soft tissue target lesion and moderate tortuosity.The vessel was pre-dilated with a nanocross 014 and post-dilated with a coyote 2 mm 014, using a terumo 6 fr sheath and a command 014 300 cm guidewire, and embolic protection was not used.Moderate resistance was encountered when advancing the device, and the distal lesion could not be crossed while the device was turned off.A guidewire wrap around the device was reported during attempted device removal, and photos were said to show the guidewire had been loaded incorrectly during setup, which was not recognized while inserting through the sheath.Device and wire removal was difficult and required transfer to the operating room, where a small approximately 3-inch surgical cut-down incision was performed to remove the device and guidewire.The case was completed by treating below the knee with percutaneous transluminal angioplasty balloons at the anterior tibial and patient segment only.The patient was reported to be stable, alive, and without injury, and the device was reported to have been safely removed without vessel damage.No patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Image analysis the customer returned six images for evaluation 3082: this image depicts a fluoroscopic image and the guidewire can be visualized as looped around the hawkone device 3083: this image depicts a guidewire advanced through the lumen of the distal tip but not advanced through the guidewire lumen of the housing of the tip 3084: this image depicts the housing of the hawkone device on a piece of surgical gauze; a guidewire is advanced through the lumen of the distal tip but not advanced through the guidewire lumen of the housing of the tip.3085: this image depicts the housing of the hawkone device on a piece of surgical gauze; a guidewire is advanced through the lumen of the distal tip but not advanced through the guidewire lumen of the housing of the tip.Proximal to the tip the guidewire appears to be looped around the device.3086: this image depicts the housing of the hawkone device on a piece of surgical gauze; a guidewire is advanced through the lumen of the distal tip but not advanced through the guidewire lumen of the housing of the tip.Proximal to the tip the guidewire appears to be looped around the device.3087: this image depicts the housing of the hawkone device on a piece of surgical drape; the device has been cut proximally to the distal tip of the device.A guidewire is advanced through the lumen of the distal tip but not advanced through the guidewire lumen of the housing of the tip.The guidewire lumen is visible on the tip of the housing but it is not possible to detect if the lumen is damaged or detached.Additional information: the physician improperly loaded the wire.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: 24729263
• Report Number: 9612164-2026-01623
• Device Sequence Number: 9286961
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: (01)00643169968356(17)280817(10)0012974886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H1-S
• Device Lot Number: 0012974886
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 08/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female