BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HURRICANE¿ RX

    MDR report key: 2830435 · Received November 13, 2012

    Report

    Report Number
    3005099803-2012-05141
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K001338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS UNKNOWN. (B)(4). INVESTIGATION RESULTS VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE CATHETER TO BE INTACT; HOWEVER, THE TUNNEL (EXIT MARKER) WAS FOUND TO BE DAMAGED, CREASED, ACCORDIONED, AND SEEMED TO BE SMASHED. THE BALLOON WAS FOUND STILL IN ITS WINGFOLDED CONFIGURATION, NO WINGTOOL WAS PRESENT. A TEST GUIDEWIRE WAS INSERTED THROUGH THE TIP OF THE CATHETER AND DID NOT PASS THE TUNNEL AS RESISTANCE WAS ENCOUNTERED DUE TO THE TUNNEL BEING DAMAGED/SMASHED MAKING IT IMPOSSIBLE FOR WIRE TO PASS UNDERNEATH. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THIS COMPLAINT AS IT IS MOST LIKELY THAT THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE DURING PROCEDURE OUTSIDE THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX BILIARY BALLOON DILATATION CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, IN THE COMMON BILE DUCT (CBD). ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, OUTSIDE THE PATIENT, THE GUIDEWIRE WOULD NOT COME OUT OF THE RX CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ON (B)(4) 2012, EVALUATION OF THE COMPLAINT DEVICE BY THE INVESTIGATION SITE REVEALED THE EXIT MARKER WAS BUNCHED UP, WHICH WAS NOT INITIALLY REPORTED BY THE ACCOUNT; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HURRICANE¿ RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00545900 15368575

    Patients

    Seq Age Sex Outcome Treatment
    1