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); Difficult to Advance (2920)

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a hawkone directional atherectomy along with non-medtronic 6fr sheath and 0.014" x 14 guidewire during procedure to treat a moderately calcified lesion in the left distal superficial femoral artery (sfa), popliteal artery (pop) and tibial/popliteal trunk (tpt) with chronic total occlusion (cto-100%).The vessel was little calcified.The vessel diameter and lesion length are 6mm and 30mm respectively.Not specified if embolic protection was used.The vessel was pre dilated but not post dilated.Ifu was followed.It was reported that during withdrawal, moderate resistance was encountered and tip detached.It was separated at the hinge pin.Antegrade access with difficult sheath manipulation and angle was experienced.Hawkone was difficult to remove due to angle of sheath.No prolapse was present.It was reported that the device separated within the sheath during removal which prompted ending procedure immediately due to removal of entire sheath to ensure complete device retrieval.The tip came off entirely in the sheath therefore the sheath had to removed immediately to ensure complete retrieval of the device.Access was lost.Hemostasis was difficult to achieve due to anatomical features of the patient.Because the sheath was removed and due to anticoagulation, bleeding was difficult to control and led to an urgent response to stabilize the patients vital signs.A prolonged period of manual pressure to control bleeding along with administration of medication to reverse heparin.This likely caused thrombus in the lower leg which required surgical evacuation.Vessel occlusion due to thrombus were complications associated with this event.Patient went to surgery for thrombectomy to complete the procedure.The device itself did not directly cause patient to go to surgery however the device coming apart in the sheath directly led to premature ending of the case.Patient had successful surgery, spent the night and went home.No further patient injury was reported.

Manufacturer Narrative

Image analysis images 1 and 2 show a detached tip and the distal end from a hawk-one device.An analysis shows that the tip is detached distal to the anchor pockets and not at the hinge pins.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: 13858224
• MDR Text Key: 287677631
• Report Number: 9612164-2022-01106
• 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
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010603931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• Date Device Manufactured: 03/15/2021
• 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 Sex: Male