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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND HAWKONE DIRECTIONAL ATHERECTOMY CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Lot Number 0010155376
Device Problem Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/13/2020
Event Type  Injury  
Event Description
Procedures: up and over selective angiogram of the left femoral popliteal artery; up and over atherectomy of the entire superficial femoral artery; attempted snaring the fox hollow device and wire from the right common femoral artery/right iliac artery and attempts narrowing it also from the left common femoral artery. Cv consulted for cut down retained device and wire. After completing the atherectomy was noted on the fluoroscopy that the medical bro wire was wrapped around the atherectomy device and caught at the junction of the cutting section preoperative diagnosis: retained atherectomy catheter in the left femoral vessel. Postoperative diagnosis: retained atherectomy catheter in the left femoral vessel. Procedure: left femoral exploration, removal of retained catheter from distal superficial iliac artery, common femoral artery endarterectomy and primary repair of common femoral artery. Fda safety report id#. (b)(4).
 
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Brand NameHAWKONE DIRECTIONAL ATHERECTOMY
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
MDR Report Key10927358
MDR Text Key219137439
Report NumberMW5098147
Device Sequence Number1
Product Code MCW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0010155376
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/30/2020 Patient Sequence Number: 1
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