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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number H1-LX
Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used hawkone directional atherectomy along with 7fr sheath, a non-medtronic guidewire and 6mm embolic protection during procedure to treat a moderately calcified lesion in the mid to distal left superficial femoral artery (sfa) with chronic total occlusion (cto-100%). The vessel diameter was 6mm. The vessel was not pre or post dilated. Ifu was followed. During withdrawal, severe resistance was felt and the tip detached/damaged. The hawkone tip was stuck inside the sheath pulling the spider with it. Physician was unable to take final pictures to assess damage after losing wire. Ultrasound will be performed in the afternoon post procedure. Physician was unable to complete, access was lost. Patient complication associated with this event is access site hemorrhage/bleed. No further patient injury reported.
 
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Brand NameHAWKONE 7F
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10828322
MDR Text Key215919450
Report Number9612164-2020-04392
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141801
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-LX
Device Catalogue NumberH1-LX
Device Lot Number0010287165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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