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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); Difficult to Advance (2920)
Patient Problem Vascular Dissection (3160)
Event Date 10/03/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use hawkone to treat a severely calcified lesion in the distal superficial femoral artery (sfa) and popliteal artery. The lesion was diffuse and artery diameter was 5mm. The vessel presented moderate tortuosity. Ifu was followed during preparation, procedure and post procedure. The vessel was pre and post dilated. Moderate resistance was felt during advancement. It was reported that the cutter/nosecone separated from the catheter. Vessel damage/dissection is reported. An enlarged incision was performed to remove de catheter and all detached component from the patient. The procedure was completed with balloon angioplasty.
 
Manufacturer Narrative
Product analysis: the hawkone device was returned connected to a cutter driver. It was observed the hawkone was loaded over a spider fx capture wire which was fractured. No other ancillary devices were included. The hawkone was fractured apart at the distal assembly. The fracture occurred at the proximal location of where the coiled segment of the housing initiates and distal to the anchor pockets. The distal segment which fractured off showed the capture wire loaded the rotating tip of the distal assembly. The guidewire tubing of the housing was disengaged at the proximal end and progressed to zipper tearing towards the distal tip. The tecothane remained intact and had rounded edges at the proximal end. The area where the tecothane was over the anchor pockets was visible. The coils from the housing showed stretching/ elongation within the tecothane. The fracture was ductile in nature. The spider fx showed biological debris within the exposed filter. No damage to the filter assembly which was exposed outside of the distal tip. The proximal end of the spider fx capture wire was approximately 14cm. The proximal end of the spider fx capture wire showed the ptfe skived off. The proximal segment of the hawkone showed the cutter assembly and the drive shaft protruding out from the radial fracture of the housing approximately 2cm. Pet was observed within the cutter window. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: it is unknown if the tip separated at hinge pins. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the tip detached during device advancement in the very diseased , highly calcified area of the lesion. The detached component never came off the wire and it was maintained entirely over the spider wire. Patient is doing fine and had opposite leg treated 1 week later. 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 Key9271440
MDR Text Key164832329
Report Number9612164-2019-04615
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 Health Professional,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/02/2021
Device Model NumberH1-M
Device Catalogue NumberH1-M
Device Lot Number0009472026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0450-2022

Patient Treatment Data
Date Received: 11/04/2019 Patient Sequence Number: 1
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