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

Model Number H1-M

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

Physician was attempting to use a hawkone directional atherectomy along with a non-medtronic 6fr sheath, a 6mm spider fx guidewire and embolic protection during procedure to treat a little calcified plaque lesion in the left proximal popliteal artery (pop) with chronic total occlusion (cto-100%).The vessel was little tortuous.The vessel diameter and lesion length are 5mm and 100mm respectively.The vessel was pre dilated but not post dilated.Ifu was followed.Guidewire advancement/prolapse occurred.The device was advanced over bifurcation.The guidewire was hydrated at preparation.During withdrawal, minimal resistance was felt.The guidewire prolapse did not cause tip damage or embolization during procedure.The guidewire lumen was not torn and it did not lock-up on the catheter.It was reported that the hawkone would not pack.The device would turn on and shave but the packer would not slide forward into the nosecone.Device was withdrawn from patient but secondarily encountered wire prolapse.After the h1-m was discovered to not be packing, the physician attempted to withdraw the device but felt a small resistance at the sheath.Physician carried out fluoroscopy of the sheath and discovered a wire loop.The spider wire would not push forward to reduce the loop and the sheath began to accordion.The entire system was abandoned and manual pressure was held.There was no patient injury.

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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the cutter was in the window as the device was being removed from the patient.This particular m device would not pack and so the blade would not advance into the nosecone with the thumbswitch.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.

Manufacturer Narrative

Additional information: the wire had to be cut to free the device from the sheath.The lesion was treated with several passes of the h1-m device but, after it was discovered to not pack, the device was attempted to be removed.When wire wrap was terminally unsolvable, the sheath access was abandoned.The device was cleaned afterwards and it had picked up plaque in the nosecone, so the lesion was atherectomized but not followed up with any sort of balloon or dcb.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.

Manufacturer Narrative

Product analysis the device was received with the thumbswitch positioned halfway between the ¿on¿ and ¿off¿ position the cutter was positioned approximately 8mm in the housing and is blocked by biologics present in the housing the thumbswitch was advanced but the cutter was stopped by the biologics.The housing was flushed as per ifu, but all the biologics could not be removed.The thumbswitch was advanced again but the cutter would only advance approximately 16mm in the housing before being was stopped by the remaining biologics image analysis the customer returned two images.Image 1 appears to show a device in a patient¿s vasculature.There appears to be evidence of a guidewire prolapse.Image 2 shows a hawkone device with a guidewire prolapse.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
• Type of Device: 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: 14974775
• MDR Text Key: 303223092
• Report Number: 9612164-2022-02579
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/07/2022

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
• Device Operator: Health Professional
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010967815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 07/05/2022; 07/11/2022; 10/06/2022
• Supplement Dates FDA Received: 07/11/2022; 07/14/2022; 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male