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

Catalog Number	H1-M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: device was decontaminated with cidex opa solution soak and tergazyme soak.The device was returned with its tip detached.A visual inspection found that the tip is detached distal to the anchor pockets.The detached tip was not returned.Additional information: prolapse did not result in intervention for removal of the devices, physician was able to remove the device with the sheath, the device was stuck in the sheath.Interaction with the atherectomy device did not lead to any detachment on the spider.The device was pulled into the sheath and became stuck in the sheath, while pulling the device the tip of the device separated at the hinge point.The sheath was then removed with the distal portion of the hawkone stuck in the sheath, then the spider fx wire was cut and a new sheath was introduced over the spider fx wire that remained in vitro and then the remaining spider fx wire and filter were removed without incident.The case was finished with a new destination sheath and wire and a in.Pact dcb was used to finish the case.There was no injury to the patient.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 an atherectomy h1-m hawkone m was used to treat a peripheral artery target lesion in the left mid popliteal artery that was calcified with severe calcification, 95% stenosis, 25 mm lesion length, and 6 mm vessel diameter, with minimal tortuosity.The vessel was pre-dilated using a 3x40x130 nanocross, and embolic protection was used with a 7 mm spiderfx 320 mm.Moderate resistance was encountered when advancing the device, and device tip damage was noted.During the procedure in vivo, the device tip detached at the hinge pin, and guidewire prolapse was reported to have led to the tip detachment.The detached tip was removed within the sheath, and the device was safely removed from the patient.After removal of the device and sheath, wire position was maintained, a new sheath was inserted, and the lesion was ballooned with a drug-coated balloon to complete the procedure, with post-dilation performed using adm06006013p.The patient was reported alive with no health consequences or impact.
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.

• 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: 25160509
• Report Number: 9612164-2026-02480
• Device Sequence Number: 8661845
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: (01)00643169968332(17)290115(10)0013238563
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/11/2026

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: 0013238563
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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 Age: 82 YR
• Patient Sex: Male