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

Catalog Number	H1-LX
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
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
Physician attempted to use a hawkone lx atherectomy device with a 7fr non-medtronic sheath and a spider fx embolic protection device/guidewire during treatment of a 200mm fibrous plaque lesion in the patients right mid distal superficial femoral artery (sfa).Minimal vessel calcification was reported.Lesion exhibited 80% stenosis.Artery diameter reported as 6mm.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.The vessel was not pre-dilated.The vessel was post-dilated with a non-medtronic device.The device was passed through a previously deployed stent.No resistance was encountered when advancing the device.It was reported that the hawkone lx device completed passes and was safely removed from the patient to clean it.Upon flushing the device to remove the plaque, a small piece of foreign material/black plastic exited the flush window.The material was suspected to be a part of the device.The material was not pet liner.The device was wiped down prior to use.No foreign material was left inside of the body and no complications with the patient.A replacement hawkone lx device was opened and used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Product analysis the device was returned with the thumbswitch in the ¿off¿ position and with the distal flush tool (dft) positioned over the housing, the dft was retracted, and the cutter was positioned in approximately 28mm inside the housing a black piece of foreign material was returned, the black seal on the dft was removed, and it was found that there was a portion of the black seal missing, the returned black piece of foreign material matches up with the missing portion of the black dft seal image review the customer returned one image.The image shows a piece of black material.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: 20565746
• Report Number: 9612164-2024-04966
• Device Sequence Number: 7988415
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: 00643169968509
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/20/2024

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: 0012310297
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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: Female