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

Model Number	H1-LS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use the hawkone directional atherectomy device along with a non-medtronic 7fr sheath, a 0.014" spider wire and 5mm embolic protection during procedure to treat severely calcified lesion in the right mid distal superficial femoral artery (sfa) with chronic total occlusion (cto-100%).The vessel was pre and post dilated.Ifu was followed.It was reported that after cleaning the device it appeared that the cutter would not close fully.When the device was used to complete more passes inside the body the nosecone would become full after only one pass.When the device was removed from the patient and subsequently cleaned, it was noted that the cutter would not close all the way.A new device was used to complete the procedure.No further issues observed.No patient injury.
Additional Manufacturer Narrative
Additional information: it was possible to turn off the thumb switch.The device did not stop functioning inside the patient.Cutter was inside housing when device was removed from patient.Device was safely removed from patient.No deformation of the cutter was observed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 13861082
• Report Number: 9612164-2022-01114
• Device Sequence Number: 5296578
• Product Code: MCW
• UDI-Device Identifier: 00643169968486
• UDI-Public: 00643169968486
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/24/2022

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 Expiration Date: 10/12/2024
• Device Model Number: H1-LS
• Device Catalogue Number: H1-LS
• Device Lot Number: 0010894275
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 03/24/2022
• Date Device Manufactured: 10/13/2021
• 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 Age: 79 YR
• Patient Sex: Female