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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. HAWKONE MADE BY MEDTRONIC DIRECTIONAL ATHERECTOMY SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC, INC. HAWKONE MADE BY MEDTRONIC DIRECTIONAL ATHERECTOMY SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number H1-S
Device Problems Break (1069); Difficult to Insert (1316)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/14/2020
Event Type  Injury  
Event Description
Pt with peripheral vascular disease, limb ischemia; procedure was turbohawk directional atherectomy of right posterior tibial artery. Selective rt lower extremity angiography was obtained, dr exchanged sheaths for a 6 french raabe sheath given plan for atherectomy and his tortuous arteries. Used 0. 014 command wire and a seeker cath to advance to the pt at the ankle. Confirmed in the true lumen. Tried to advance the hawkone unit; however, it would not pass through the pt, removed the device and used a 2mm balloon to treat the entire pl artery. Passed the device easily and performed atherectomy in multiple directions. Results excellent. When removing device, it caught when being resheathed and tip (nosecone) broke off. Dr removed the remainder of the device. It was clear the tip was stiff connected to the wire. Removed the entire sheath and wire as one unit in hopes of successfully removing the foreign body from the arterial system. Pulled the wire back as much as possible to get the majority of the device within the sheath, after removing the sheath, it was clear the foreign body remained in his left groin. Confirmed on fluoro. Marked his groin where foreign body appeared to be and took him to surgery emergently to remove the foreign body and also control the bleeding.
 
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Brand NameHAWKONE MADE BY MEDTRONIC DIRECTIONAL ATHERECTOMY SYSTEM
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key10717886
MDR Text Key212732534
Report NumberMW5097380
Device Sequence Number1
Product Code MCW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 10/21/2020 Patient Sequence Number: 1
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