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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); Device Damaged by Another Device (2915); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2020
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 3mm spider fx and non-medtronic 6fr sheath during treatment of a 60mm, calcified cto (chronic total occlusion-100%) in the patient¿s mid and distal popliteal artery of reported diameter 4mm. Moderate vessel calcification is reported. Ifu was followed. Vessel pre-dilation and post-dilation was performed. The guidewire was hydrated at preparation. It is reported that the device was advanced over the bifurcation but that the moderate resistance was noted during withdrawal of the device. Tip damage is reported. The physician reports the guidewire was bunching and was noted by the end of the sheath during removal. The physician advanced the hawkone back down the wire and was able to resolve the wire wrap/bunching issue. The physician then removed the device from the patient with no further difficulty. Upon cleaning the device, a piece of black material was noted on the flush towel. A new hawkone was opened, and the procedure was completed successfully over the original spider wire, which was never removed from the patient. Post-dilation was performed with an inpact admiral drug coated balloon. No patient injury reported.
 
Manufacturer Narrative
Additional information: the source of the black material is unknown. There was no harm to the patient during this procedure, so the material had no effect on the outcome. There was no component detachment observed during the case and no visible issues with the device on inspection.  the cutter was housed in the nose cone, in the off position when the device was removed from the patient. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key10592447
MDR Text Key208741945
Report Number9612164-2020-03651
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2020
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 Number0010155368
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/27/2020
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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