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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)
Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Event Date 04/13/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was using a hawkone directional atherectomy device along with a non-medtronic 6fr 45cm sheath and 0. 014" guidewire during procedure to treat a severely calcified lesion in the tibial/popliteal trunk (tpt). The vessel was moderately tortuous. No embolic protection was used. The vessel was pre dilated. Ifu was followed. It was reported that during withdrawal, moderate resistance was felt and the tip detached. The tip did not separate at the hinge pin. It is unknown if a guidewire prolapse occurred. The opaque, rotating tip of the nosecone detached. The rest of the nosecone was removed safely from the patient. Upon removal of the device from the patient after initial passes, the detached component was embolized in patient's vessel. Intervention carried out was component jailed/tacked to the vessel wall. The tip was successfully stented against the vessel wall in the tibial peroneal trunk using a 5mm coronary stent, trapping it. 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 Key14140286
MDR Text Key289484854
Report Number9612164-2022-01491
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
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
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 Number0010915683
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/28/2021
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: 04/19/2022 Patient Sequence Number: 1
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