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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VOLCANO CORPORATION PIONEER PLUS CATHETER TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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VOLCANO CORPORATION PIONEER PLUS CATHETER TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number PPLUS120
Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problem Occlusion (1984)
Event Date 11/03/2020
Event Type  malfunction  
Event Description
The right external iliac artery was occluded, and a wire would not pass. The md was planning to put a stent into that artery. Because the wire would not pass, per the op note, "this necessitated the use of a pioneer reentry device with an 0. 014 wire and chromaflo guided intravascular ultrasound with a reinjury system and gaining access into the common iliac artery and ultimately into the level of the aorta. " the second surgeon in the case described it like this: "we attempted to cross the lesion within the true lumen; however, the plaque was significant within the external iliac artery. We used a pioneer reentry device with a 0. 014 wire and chromaflo to orient the reentry device towards the arterial aspect. This was reentered just distal to the hypogastric artery. We were able to place a 0. 014 wire up to the level of the aorta. " during a stenting procedure to the right external iliac artery of a patient with profound atherosclerotic disease with bilateral lower extremity disabling claudication secondary to severe aortoiliac and bilateral iliofemoral atherosclerotic disease, a guide wire became lodged, in the pioneer plus dual-guidewire catheter (wire got stuck in the pioneer plus catheter)and broke. Both the wire and pioneer plus dual-guidewire catheter had to be removed from the patient and a new device and wire were opened to complete the procedure. Patient recovered without any issues. A representative from volcano (manufacturer) now has possession of the device.
 
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Brand NamePIONEER PLUS CATHETER
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
VOLCANO CORPORATION
2870 kilgore road
rancho cordova CA 95670
MDR Report Key10918799
MDR Text Key218673104
Report Number10918799
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPPLUS120
Device Catalogue NumberPPLUS120
Device Lot Number4923956
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/25/2020
Event Location Hospital
Date Report to Manufacturer11/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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