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

Model Number H1-M

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

Patient Problem Injury (2348)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a hawkone device with a non-medtronic 0.014 wire and 6fr sheath during treatment of a 60 mm, calcified cto (chronic total occlusion-100%) in the patients mid and distal left superficial femoral artery <(>&<)> popliteal artery.Severe vessel tortuosity and calcification are reported.Vessel diameter reported as 7 mm.Angiogram performed showing cto in the patient¿s left proximal sfa and distal sfa.The left iliac was very tortuous.Pta and stenting performed in the left proximal sfa.The hawkone device was then used to treat the distal left sfa.Following completion of atherectomy, when the physician attempted to remove the hawkone, the tip of the device broke off attached to a non-medtronic wire.The physician swapped out the 6fr sheath for 7fr and used a gooseneck snare.Physician had to re-access through the foot using a 7fr sheath and gooseneck snare device.Physician was successful snaring the broken wire and tip through the left anterior tibial artery.

Manufacturer Narrative

Additional information: all parts of the device were captured and removed from the patient.The re-access through the foot was carried out as physician could not snare from up and over through the sheath.Part of the broken non-medtronic wire was in the distal sfa and it was easy to capture from retrograde foot access.No further intervention was required.The patient is doing fine and there is no adverse event reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: the hawkone was inspected and found the distal assembly was fractured apart into two pieces.The fracture occurred at the proximal end of the housing where the coils initiate, distal the anchor pockets.The distal segment was inspected.And found the 0.014" guidewire was exposed approximately 57cm from the distal tip of the hawkone rotating tip.The distal assembly which fractured off was approximately 6cm long.The proximal end of the gw tubing of the housing was flared out and protruding out from the housing.The proximal end of the guidewire appeared to be cut by a sharp instrument.The proximal end of the detached housing showed the tecothane intact with rounded edges.The coils of the housing were stretched out proximally past the tecothane.The other segment of the hawkone showed the radial fracture face of the housing distal the anchor pockets.The drive shaft was advanced/exposed with the cutter assembly attached.It was observed pet from the id of the housing was identified behind the cutter.Image review: the customer provided cine images of the procedure.The provided images have been reviewed and identified the reported tip detachment at the proximal end of the housing.The order of the provided images is not in chronological order.Image 1: image of the vessel likely prior to treatment.A distal end of a guidewire was identified.Images 2, 8: show the hawkone distal assembly and the torque shaft intact as one unit.Images 3, 4, 5, 7: the image quality could not distinctly identify the components of the hawkone device.Image 10: photo of the fractured distal assembly detached at the proximal end of the coil segment of the housing.Images 6, 9, 11: show the housing separated from the area of the cutter driver within the vessel.If information is provided in the future, a supplemental report will be issued.

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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9160834
• MDR Text Key: 162252552
• Report Number: 9612164-2019-04249
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009773948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/18/2019; 12/13/2019; 01/19/2022
• Supplement Dates FDA Received: 10/23/2019; 12/17/2019; 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0450-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 85 KG