BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HURRICANE¿ RX

    MDR report key: 2870722 · Received December 12, 2012

    Report

    Report Number
    3005099803-2012-05938
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    June 11, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K001338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DISTAL TIP BENT. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE BALLOON TO BE IN THE WINGFOLDED POSITION, NO WINGTOOL WAS PRESENT. THE CATHETER WAS INSPECTED FOR COSMETIC DEFECTS AND NONE WERE FOUND; HOWEVER, THE DISTAL TIP OF THE CATHETER WAS FOUND TO BE SLIGHTLY BENT. NO OTHER DEFECTS WERE NOTED. THE REPORTED DEFECT OF CATHETER KINKED/BENT WAS NOT CONFIRMED. THERE WERE NO KINKS NOTED ON THE CATHETER SHAFT; HOWEVER, THE DISTAL TIP WAS FOUND TO BE SLIGHTLY BENT. THE DISTAL TIP MOST LIKELY BENT WHILE HANDLING THE DEVICE DURING PREPARATION (POSSIBLY WHILE UNRAVELING THE CATHETER FROM ITS COILED CONFIGURATION). THEREFORE, BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION RESULTS, THE MOST PROBABLE ROOT CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THIS COMPLAINT. 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 A PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CATHETER KINKED. 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 STABLE. ON (B)(6) 2012 EVALUATION OF THE COMPLAINT DEVICE BY THE INVESTIGATION SITE REVEALED THE DISTAL TIP TO BE BENT, 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 15066786

    Patients

    Seq Age Sex Outcome Treatment
    1