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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-INT
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use the hawkone atherectomy device during procedure to treat calcified lesion in left superficial femoral artery (sfa). Tip damage/detachment is reported. Resistance was felt during withdrawal. It was reported that after removing the material and cleaning, the catheter-tip broke off when it was pulled back. The tip did separate at the hinge pin. No patient injury.
 
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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 Key13901599
MDR Text Key290809945
Report Number9612164-2022-01176
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberH1-M-INT
Device Lot Number0010639890
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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