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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 Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/30/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician used hawkone to treat a cto (chronic total occlusion-100%) of the mid right superficial femoral artery (sfa). The vessel presented moderate tortuosity. A non-medtronic 6 fr x 45 cm sheath was used. Ifu was followed. It was reported that during removal of the device after successful atherectomy of the sfa, the nosecone detached, at the hinge pin, from the device outside of the sheath. The nosecone was snared using a gooseneck snare and removed. The hinge pins were captured with the nosecone. No deformation was noted to the cutter. No patient injury was reported.
 
Manufacturer Narrative
Device evaluation: the hawkone was received with the cutter attached to the cutter driver and the catheter load into a support sheath. The cutter distal assembly coil section exhibited a circumferential fracture at the proximal end of the coil, exposing the cutter head and drive shaft. 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 Key8133670
MDR Text Key129349118
Report Number9612164-2018-03478
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
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/21/2021
Device Catalogue NumberH1-M
Device Lot Number0009393725
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2018
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: 12/05/2018 Patient Sequence Number: 1
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