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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 Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2020
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 7fr sheath and non-medtronic guidewire during treatment of a 150mm fibrous and plaque cto (chronic total occlusion-100%) in the patient¿s mid and distal right superficial femoral artery and popliteal artery. Slight vessel tortuosity and moderate calcification are reported. Artery diameter reported as 5mm. Ifu was followed. Vessel pre-dilation was not performed. Its is reported after making 2 passes the thumbswitch would not fully retract into the off position as there was plaque that would not allow for complete off position. There was no damage noted to the device cutter. The device was removed from the patient for inspection. No vessel damage was noted. A large plaque was removed from the device. Additionally, there was some wired blue coloured string like material in the cutter blade and within the flush port. It was initially though it was towel but the towel was not near when the device was removed and had not come into contact with the device. Possibly sheath lining. The procedure was then completed by pta and dcb. No 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
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key10933729
MDR Text Key219164874
Report Number9612164-2020-04719
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
Report Date 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
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 Manufacturer01/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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 Initial

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