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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND HAWKONE 7FR CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number T
Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluation visual inspection: the hawkone was inspected and found the distal assembly was stretched out at the proximal portion of the coiled housing edge and distal the anchor pockets. The tip remained attached connected to the housing. The tecothane was disengaged from the cutter window portion of the distal assembly. The proximal end of the guidewire tubing showed partial longitudinal tearing. The housing was bent approximately 3cm distal the cutter window. 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 spider fx during treatment of a calcified lesion in the patient¿s proximal right superficial femoral artery (sfa). Moderate vessel calcification is reported. Lesion exhibited 70-80% stenosis. Ifu was followed. Vessel pre-dilation was performed. Several passes were made with the hawkone device. When the physician attempted to insert the device to make the final pass, the physician felt severe resistance during advancement and the hawkone catheter could not be pushed forward due to it becoming entangled in the spider fx device. The physician then removed the hawkone catheter and spider fx. The procedure was completed using a non-medtronic (mustang) balloon and inpact pacific drug-coated balloon. The physician attempted to flush the spider fx and hawkone devices following removal from the patient and observed some plastic debris from the nosecone. The physician suspects the plastic debris is from the nosecone after several uses of the hawkone, as some part of the material peeled off from the nosecone. There was no detached components. The cutter was located inside the housing during device removal from the patient. No patient injury reported. When the device was returned to the manufacturing facility, it was noted that the device was damaged.
 
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Brand NameHAWKONE 7FR
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 Key11202321
MDR Text Key227787319
Report Number9612164-2021-00243
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeTW
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 02/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberT
Device Catalogue NumberH1-LS-INT
Device Lot Number0010105781
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2020
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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