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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 Advance (2920); Material Deformation (2976); Positioning Problem (3009); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
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 the hawkone atherectomy h1-m device along with non medtronic 6fr sheath and 0. 014" guidewire to treat a little calcified soft tissue lesion in the proximal superficial femoral artery(sfa). The vessel was little tortuous. This was a bypass graft present. The vessel was post dilated and ifu was followed. It was reported that the hawkone was unable to cross. There was moderate resistance on initial advancement. The physician was able to use the hawk hm-1 for the proximal lesion but it did not pack and was not possible to advance. The orange switch would not move forward after the first pass. Upon inspection it looked as if the blade was stuck in the cutter window. When the physician tried to move it forward the plunger came out through the cutter window outside of the nosecone. Cutter was not in nosecone during removal because it would not go forward. No difficulty removing the device. No damage noted to tecothane jacket noted. No detachment occurred. The procedure was completed by using a 0. 014" nanocross device followed by a hawkone h1-s device. 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
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 Key12359052
MDR Text Key267850149
Report Number9612164-2021-03262
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 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2021
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 Number0010603933
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2021
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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