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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); Device Damaged by Another Device (2915); Difficult to Advance (2920)
Patient Problem Insufficient Information (4580)
Event Date 10/04/2021
Event Type  Injury  
Event Description
Physician was attempting to use the hawkone atherectomy device along with nitrex guidewire during procedure to treat a lesion in right superficial femoral artery (sfa). Ifu was followed. It was reported that tip detachment occurred. Severe resistance was felt during withdrawal. The tip did separate at the hinge pin. When removing the hawkone m device they met resistance. It was discovered that they had wire prolapse. Wire prolapse caused embolization. After trying to push and pull the device it eventually would not move anymore. Attempted advancing the wire and pulling back. Nothing would move. Physician attempted to pull device again. The tip sheared off. Physician used a snare and retrieved the tip. No vessel damage. No patient injury 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 Key13653316
MDR Text Key287344303
Report Number9612164-2022-00858
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 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
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 Received02/09/2022
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: 03/02/2022 Patient Sequence Number: 1
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