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

Model Number H1-M

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)

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

Event Date 11/13/2020

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 0.014 non-medtronic wire during treatment of a plaque cto (chronic total occlusion-100%) in the patient¿s proximal left superficial femoral artery (sfa).Slight vessel tortuosity and no calcification are reported.Ifu was followed.Vessel pre-dilation was not performed.It is reported that severe resistance was felt during withdrawal when the physician attempted to pull the device into the sheath.Imaging revealed the wire prolapsed.The device was advanced out of the sheath to straighten the wire, but it kinked just proximal to the wire lumen on the hawkone and could not be pulled back into the sheath.The physician then attempted to pull everything out as a unit but when the hawkone device reached the arteriotomy it became stuck.The physician continued to pull on the catheter and the tip detached from the device.The procedure was stopped with the wire and nosecone left in the common femoral artery.The patient was sent to surgery for removal.No further injury reported.

Manufacturer Narrative

Additional information: this was an up and over selective angiogram of the left femoral popliteal artery.Up and over atherectomy of the entire sfa.The non -medtronic wire was wrapped around the hawkone device and caught at the junction of the cutting section.The retained device components were in the left femoral vessel.Device components removed via exploratory procedure from the distal superficial iliac artery, c ommon femoral artery endarterectomy and primary repair of the common femoral artery.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: all detached components were successfully removed from the 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.

Manufacturer Narrative

Product analysis: the hawkone was returned to medtronic investigation lab for analysis.The device was returned connected to a cutter driver was returned with a non-medtronic 0.014¿ guidewire and a non-medtronic 6fr sheath attached to the device and coiled inside a biohazard bag.The tip of the hawkone detached distal to the anchor pocket and was not returned for analysis.Microscopic inspection confirmed no damage to the cutter and part of the tecothane was detached and bunched around the cutter.Microscopic inspection of the drive shaft revealed the fracture faces on the cutter window assembly.No other damages were noted to the returned 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.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 10867889
• MDR Text Key: 217106963
• Report Number: 9612164-2020-04496
• 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
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010155376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention