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

Model Number	H1-S
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	08/09/2021
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 a hawkone atherectomy device for treatment of a little calcified, little tortuous, plaque lesion presenting with chronic total occlusion in the mid superficial femoral artery.Artery diameter was 5mm, and lesion length 200mm.A 6fr non-medtronic sheath and nitrex 0.014 300cm was used.No embolic protection used.Ifu was followed.It was reported that upon withdrawal of the device mild resistance was felt by the physician within the contralateral sheath.The device then separated approximately at the area of the cutter window.The device was within the sheath.The sheath was then removed from the patient with the separated piece within the sheath.A new sheath was placed over the wire and the procedure was completed with no harm to the patient, with complete removal of the separated portion of the device.Resistance felt was minimal.Procedure was completed with new hawkone (h1-s) device.No patient injury reported.
Additional Manufacturer Narrative
Additional information: no wire prolapse was noted.The wire was able to be removed from the device.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
Device evaluation visual inspection shows damage noted to the torque shaft just distal to the strain relief.The detachment site is noted just distal to the anchor pockets.Destructive testing was performed on the returned 6fr sheath and the detached tip assembly was removed from within the sheath.Inspection under a microscope shows the detachment site clearly just distal to the anchor pockets.The cutter returned distal to the cutter window and retracted back to the widow but will not advance further.Both hinge pins are intact and visible.A 0.014¿ guidewire from the lab was front loaded via the tip and exited out the proximal end of the gw lumen with no issues.No damage noted to the nosecone.Biologics/plaque are visible inside the flush window and housing.Frayed coils are noted at the proximal end of the housing at the detachment site.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
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 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12314303
• Report Number: 9612164-2021-03117
• Device Sequence Number: 19624244
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: 00643169968356
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/16/2022

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: 03/29/2024
• Device Model Number: H1-S
• Device Catalogue Number: H1-S
• Device Lot Number: 0010623856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 09/14/2021; 01/19/2022
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 08/19/2021; 09/14/2021; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0451-2022
• Patient Sequence Number: 1
• Patient Sex: Female