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

Catalog Number H1-M

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Embolism/Embolus (4438)

Event Date 03/04/2022

Event Type  Injury  

Event Description

Physician was attempting to use a hawkone directional atherectomy along with a non-medtronic 6fr 45cm sheath and a 0.014" spider wire during procedure to treat a severely calcified lesion in the proximal superficial femoral artery (sfa).The vessel was not pre or post dilated.Ifu was followed.During withdrawal, moderate resistance was felt and the tip detached, it separated at the hinge pin.The became completely detached near the rapid exchange port.The guidewire lock-up/prolapse/lumen torn/ripped occurred.The device advanced over bifurcation but no resistance felt.Guidewire was hydrated at preparation.The guidewire prolapsed and it cause embolization.The guidewire tor from the distal tip but did not lock-up on the catheter.The tip was left in the body as was unable to be retrieved.Patient was sent to surgery for open retrieval.The target lesion was right ostial sfa.Hawkone device became stuck and tip dislodged due to wire wrap and prolapse upon removal.Multiple attempts were made to straighten out and unwrap wire with no success.Upon attempting to remove spider wire, hawk device, and sheath simultaneously the tip separated upon reaching the contra-lateral left common femoral side and became lodged into the left profunda artery.Multiple attempts were made to snare the spider wire an d tip from the contra-lateral side but were unsuccessful due to a hard protrusion from the proximal end of the tip becoming embedded in the arterial wall.Contra-lateral guide catheter and snare left in place with capture of spider wire basket and proximal tip with distal tip embedded in profunda artery.Patient was sent to the operating room for open retrieval.No further patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: a medtronic snare was used for attempted retrieval.Spider was embedded in body along with hawkone tip.Patient was sent to the operating room for open retrieval.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 returned three images of the hawkone device.Image 1 shows the detached tip along with a piece of wire.Image 2 shows the device shaft and the cutter.Image 3 is a cine and appears to show the detached tip in the patient¿s body and what appears to be a wire.Product analysis: the hawkone device was returned to medtronic investigation lab for review.The device was returned coiled inside its pouch in a biohazard bag.The detached tip was not returned.A visual inspection showed that the tip detached at the cutter window and not at the hinge pins as reported, and a section of the cutter is missing.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: 13692155
• MDR Text Key: 286743615
• Report Number: 9612164-2022-00902
• Device Sequence Number: 1
• Product Code: MCW
• 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
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male