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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND HAWKONE 7F CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number H1-LX
Device Problem Difficult to Advance (2920)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2020
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 during procedure to treat a little calcified plaque lesion in the left proximal superficial femoral artery (sfa) with 80% stenosis. The lesion was little tortuous. The vessel diameter and lesion length are 6mm and 150mm respectively. A spider wire 5. 0 filter was used as the guidewire. The wire was hydrated during prep. The device was inspected with no issues noted. The device was prepped per ifu with no issues identified. Resistance was felt during advancement of the directional atherectomy device over the guidewire. It was reported that wire wrap occurred during the second advancement. The device was advanced over the bifurcation. The wire wrap did not cause tip damage. Both devices were safely removed from the patient. The cutter could not be retracted all of the way into the housing and was reported to be between inside and outside of the housing and was not retracted all the way into the housing during device removal. There was no patient injury reported.
 
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Brand NameHAWKONE 7F
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 Key10776570
MDR Text Key214321887
Report Number9612164-2020-04196
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141801
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 12/11/2020
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-LX
Device Catalogue NumberH1-LX
Device Lot Number0010224941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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