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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 Entrapment of Device (1212); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Difficult to Advance (2920)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2020
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 a hawkone directional atherectomy with a 6fr non-medtronic sheath and a non-medtronic guidewire during a procedure to treat a lesion in the popliteal artery. Ifu was followed. Guidewire advancement/ lock-up/ prolapse/ lumen torn/ripped occurred. The guidewire was hydrated at preparation. The guidewire lumen was torn from the distal tip. Resistance was felt during advancement of the hawk over the guidewire at the end. The hawk would not track the nosecone. The wire fractured and got stuck in the device. The wire was removed in tandem and vessel access was lost. The issue occurred after multiple passes with hawk in first insertion. A pta balloon was used to complete the procedure. There was no 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 Key10777677
MDR Text Key214405562
Report Number9612164-2020-04213
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
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-M
Device Catalogue NumberH1-M
Device Lot Number0010252169
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2020
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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