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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
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
Product analysis: the hawkone device was returned.No ancillary device or images were received with the device.The device was removed from the return packaging for evaluation.The cutter driver was attached to the hawkone device.It should be noted that the torque shaft was bent beneath the strain relief.Examination of the distal assembly revealed biological debris inside the distal housing.A bend was noted approximate 0.3 cm distal to the cutter window.Microscopic inspection of the bend revealed a tear in the tecothane coating at the location of the bend; the cutter was protruding through the tear in the tecothane.The laser drilled coils in the housing were fractured at the location of the cutter protrusion.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used a hawkone device during treatment of a lesion in the patient¿s superficial femoral artery (sfa).No abnormalities reported in relation to anatomy.Ifu was followed and the device was prepped without issue.No resistance was felt during advancement.Upon fluoro imaging, prior to cutting, it was reported that the tip of the device was bent.No passes were made and no cutter deformities were noted.The device was safely removed from the patient.The device was replaced to complete the procedure.There was no patient injury.
 
Manufacturer Narrative
Device evaluation the device was removed from the return packaging for evaluation.The cutter driver was attached to the hawkone device.It should be noted that the torque shaft was bent beneath the strain relief.Examination of the distal assembly revealed biological debris inside the distal housing.A bend was noted approximate 0.3cm distal to the cutter window.Microscopic inspection of the bend revealed a tear in the tecothane coating at the location of the bend; the cutter was protruding through the tear in the tecothane.The location of the hole was on the top plane of the coiled housing (opposite guidewire tubing).The proximal edge of the hole where the cutter was exposed was flapped down and below the cutter rim.The laser drilled coils in the housing were fractured at the location of the cutter protrusion.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
HAWKONE 6FR
Type of Device
CATHETER, 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 Key8959039
MDR Text Key156424123
Report Number9612164-2019-03728
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 company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/24/2022
Device Catalogue NumberH1-M
Device Lot Number0009712603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/30/2019
Initial Date FDA Received09/04/2019
Supplement Dates Manufacturer Received09/09/2019
Supplement Dates FDA Received09/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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