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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND HAWKONE 6FR CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
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.
 
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Brand NameHAWKONE 6FR
Type of DeviceCATHETER, 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 Key13858224
MDR Text Key287677631
Report Number9612164-2022-01106
Device Sequence Number1
Product Code MCW
UDI-Device Identifier00643169968332
UDI-Public00643169968332
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
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 Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-M
Device Catalogue NumberH1-M
Device Lot Number0010603931
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0450-2022

Patient Treatment Data
Date Received: 03/23/2022 Patient Sequence Number: 1
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