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

Model Number	H1-LX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
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
It was reported that a physician was attempting to use a hawkone atherectomy device to treat a lesion in the right superficial femoral artery of a patient with plaque and little calcification with 100% stenosis.The device was prepped as per ifu.A non-medtronic sheath and a 6mm spider fx was used during the procedure.It was reported that the device was used in a patient with instant restenosis.Multiple passes were made and device with cleaned without issue.During last insertion the device did not want to close properly.The position of the cutter upon device removal from the patient is unknown.So it was removed and still would not close properly after cleaning, so another device was opened, and the case was finished without incident.No patient injury reported for this event.
Additional Manufacturer Narrative
Device evaluation device returned with the handle broken and the distal end of the handle connected to the cutter driver.The drive shaft is bent and loose therefore no functional testing can be carried out.The cutter returned inside the window just proximal to the anchor pockets.No deformation noted to the guidewire lumen or nosecone and the housing returned with no biologics present inside.Due to the condition of the returned device no functional testing could be carried out.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.
Additional Manufacturer Narrative
Additional information: the cutter was inside the housing unit when being removed from patient.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
• MDR Report Key: 11639968
• Report Number: 9612164-2021-01381
• Device Sequence Number: 3049916
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: 00643169968509
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2021

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: 10/29/2023
• Device Model Number: H1-LX
• Device Catalogue Number: H1-LX
• Device Lot Number: 0010434936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 08/05/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/28/2021; 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1