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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 Detachment of Device or Device Component (2907); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a hawkone atherectomy device with a non-medtronic 6fr sheath and 0. 014 spider fx embolic protection device during treatment of a calcified cto (chronic total occlusion-100%) in the patient¿s mid and distal superficial femoral artery (sfa). Moderate vessel calcification and tortuosity are reported. Ifu was followed and the device was prepped without issue. Vessel pre-dilation was performed. It is reported severe resistance was noted during initial advancement of the device. The device was unable to cross the lesion. The device was attempted to be removed from the patient, but severe resistance was noted on withdrawal attempt. It was observed the wire had prolapsed right outside the sheath. The hawkone was advanced and the slack was pulled from the wire which allowed for the hawkone to be pulled into the sheath. When the device reached the hub wire wrap was observed, which was successfully unwound allowing for the hawkone to be removed from the sheath. While still on the wire, just outside of the sheath, the nosecone detached from the rest of the catheter at the cutter window, the cutter/packing device stayed attached to the catheter. As detachment occurred after the physician got the hawk out of the hub of the sheath so the procedure was able to be completed normally. The device was safely removed from the patient as the separation occurred outside of the body and sheath. There was no vessel damage noted. A chocolate pta balloon was used. There was 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
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10761395
MDR Text Key213885390
Report Number9612164-2020-04148
Device Sequence Number1
Product Code MCW
UDI-Device Identifier00643169968332
UDI-Public00643169968332
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-M
Device Catalogue NumberH1-M
Device Lot Number0010145662
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0450-2022

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