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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 Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problems Vascular Dissection (3160); Embolism/Embolus (4438); Unspecified Tissue Injury (4559)
Event Date 08/27/2021
Event Type  Injury  
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 a 6fr sheath, a spider wire and 7mm embolic protection during procedure to treat a severely calcified lesion in the mid popliteal artery with 50-70% stenosis. The vessel was severely tortuous. The vessel diameter and lesion length are 6mm and 100mm respectively. The vessel was pre dilated but not post dilated. Ifu was followed. It was reported that during advancement severe resistance was felt and the tip detached at the hinge pin. The spider prolapsed and embolization occurred from debris that came out of the spider basket when snaring it. A snare was used for retrieval of t he detached tip. There was complete detachment, held in place by spider wire, never free floating in body. There was a dissection in the external iliac that occurred while trying to retrieve the device, but it was gone on follow up angio pictures. Procedure was completed by snaring and upsizing to 8fr sheath. There was no further injury to patient.
 
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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 Key12412323
MDR Text Key269633342
Report Number9612164-2021-03389
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 Health Professional,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-M
Device Catalogue NumberH1-M
Device Lot Number0010673397
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0450-2022

Patient Treatment Data
Date Received: 09/02/2021 Patient Sequence Number: 1
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