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

Model Number H1-M

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use a hawkone atherectomy device with a 6fr non-medtronic sheath and spider fx embolic protection device during treatment of a 150mm calcified lesion in the patient¿s proximal and mid right superficial femoral artery (sfa).Moderate vessel calcification and tortuosity are reported.Lesion exhibited 80% stenosis.Artery diameter reported as 5mm.Ifu was followed.Vessel pre-dilation was performed.Six passes were made with the hawkone device and the device was attempted to be removed from the patient.It is reported severe resistance was noted during withdrawal of the device and the entire nosecone of the device embolised in the vessel just below the sheath in the sfa.A gooseneck snare was used to retrieve the embolised component.After removal of the embolized nosecone, there was a small piece of what appears to metal from the nosecone embedded in the common femoral artery that remained in the patient.Following removal of the embolized hawkone nosecone and spider fx were removed, a secondary spider fx was placed, a nd an inpact admiral dcb (5x150) was used to complete the procedure.

Manufacturer Narrative

Additional information: the small piece of metal from the nosecone is still embedded in the common femoral artery.There are no plans in the future for the removal of the small piece of metal.No other intervention was required as the physician was satisfied with the final results.The patient was not given any additional treatment.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

Images received and currently under evaluation.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 spider fx was not suspected to have contributed to the detachment of the device.There was no issues reported for the spider fx and no components of the spider fx detached.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

Image review: the customer provided 5 cine images and one photo of the hawkone post-procedure outside of the patient.Cine image 1: the image shows the distal assembly of the hawkone housing inserted the vessel loaded over a guidewire.The image was able to differentiate between the proximal and distal ends.It could not be verified due to the clarity of the cine if the detachment had occurred.The proximal end of the distal assembly possibly showed the platinum iridium stretch out proximally from the tecothane layer of the housing.Cine image 2: the image shows the vessel with a vipertrack ruler in the background.A guidewire is visible within the vessel, but no hawkone or other interventional device was observed.Cine image 3: the image shows to implanted stents inserted the vessel.There was no observed damage to the implanted stents and no sign of a hawkone unit inserted.Cine image 4: the image shows the vessel with an read of noted restricted blood flow.It is possible the area of the restricted blood flow is the intended treatment area.Cine image 5: an unknown piece of possible metallic debris was observed within the vessel.The piece had a zig-zag pattern.It is unknown if the piece was from a stent, part of the hawkone, or other device.Photo #1: a photo of the distal assembly with a spider fx filter assembly located at the distal edge of the rotating tip was noted.The housing assembly of the hawkone had detached fractured off.The platinum iridium of the coiled segment showed as stretched out past the proximal edge of the tecothane.In the background a snare device was noted.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
• MDR Report Key: 10654922
• MDR Text Key: 210590692
• Report Number: 9612164-2020-03848
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2023
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010263029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 88