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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
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.
 
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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 Key13692155
MDR Text Key286743615
Report Number9612164-2022-00902
Device Sequence Number1
Product Code MCW
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
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberH1-M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/08/2022 Patient Sequence Number: 1
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