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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
Catalog Number H1-LS-INT
Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use hawkone directional atherectomy along with non-medtronic 7fr sheath, guidewire and a 6. 0 spider embolic protection during procedure to treat a severely calcified lesion in the proximal common iliac artery and common femoral artery with 80% stenosis. The vessel was severely tortuous. Procedural stroke cineradiography images provided. The vessel was pre and post dilated. Ifu was followed. The device was unable to cross. There was severe resistance felt during third advancement. Another hawkone device was able to cross. It was reported that physician used a non-medtronic 4. 0x80mm pta balloon for pre dilatation to prepare the lesion for the delivery channel of hawk debulking afterwards. When physician tried third advancement of hawkone-ls and felt moderate to severe resistance, however hawkone catheter finally crossed the target lesion. But when he tried to do the forth advancement, hawkone catheter was totally stuck in y connector, he gently and slowly pulled hawkone catheter out from y connector, but the nosecone was damaged and separated from the catheter. Physician then tried another smaller model of hawkone (6fr compartible) and finally debulked most of the calcified lesion and used inpact pacific 7. 0 x 80mm to complete the procedure. No patient injury.
 
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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 Key11185234
MDR Text Key228003543
Report Number9612164-2021-00208
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberH1-LS-INT
Device Lot Number0010105781
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
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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