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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); Detachment of Device or Device Component (2907)
Patient Problems Embolism (1829); Injury (2348); Embolism/Embolus (4438)
Event Date 10/21/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used a hawkone directional atherectomy along with a non-medtronic 6fr sheath during procedure to treat a moderately calcif ied fibrous lesion in the proximal to mid superficial femoral artery (sfa). The vessel was little tortuous. The vessel was no pre dilated but post dilated. Ifu was followed. During withdrawal moderate resistance was felt and the device tip detached/damaged. It is unknown if the tip separated at the hinge pin. There was renaissance in the thumb switch and it would not close at times. The tip embolized in the patient's vessel. An intervention was required to snare/retrieve device. A 5mm gooseneck snare was used to retrieve the detached tip. The procedure was finished with post dilatation. No further 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 Key10761640
MDR Text Key213884340
Report Number9612164-2020-04154
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 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-M
Device Catalogue NumberH1-M
Device Lot Number0010281782
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/30/2020 Patient Sequence Number: 1
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