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

Model Number	H1-LS
Medical Device Problem Codes	Positioning Problem (3009); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
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 hawkone directional atherectomy during procedure to treat a severely calcified lesion in the right distal, mid and proximal superficial femoral artery with chronic total occlusion (cto-100%).The vessel was little tortuous.The vessel diameter and lesion length are 6mm and 240mm respectively.The device was inspected with no issues noted.The device was prepped per ifu with no issues identified.There was resistance when advancing the device.It was reported that the hawkone would not cross the lesion.The physician removed the device and used another hawkone successfully.There was an issue closing the cutter window.The cutter was outside the housing when removed from the patient.The device was safely removed from the patient.There was no vessel damage.There was no patient injury.
Additional Manufacturer Narrative
The relevant device is not available for evaluation.No allegation of a manufacturing related failure has been reported.There are in process checks of each device just prior to packaging giving confidence that units leaving the manufacturing facility meet release specifications.The hawkone instruction for use, (ifu), provides the warning statements: ¿note: if the hawkone catheter cannot be advanced across the lesion, consider carefully removing the hawkone catheter and predilating the lesion with a small diameter balloon angioplasty catheter.¿ ¿always use direct fluoroscopic observation when manipulating the hawkone catheter in the peripheral vessels.If resistance is met during manipulation, determine the cause of the resistance before proceeding.¿ we will continue to monitor future occurrence for trending purposes.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12411565
• Report Number: 9612164-2021-03384
• Device Sequence Number: 17458201
• Product Code: MCW
• UDI-Device Identifier: 00643169968486
• UDI-Public: 00643169968486
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/26/2021

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: 04/08/2024
• Device Model Number: H1-LS
• Device Catalogue Number: H1-LS
• Device Lot Number: 0010636854
• 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: 08/26/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 11/26/2021
• Date Device Manufactured: 04/09/2021
• 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 Sex: Male