BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER

    MDR report key: 2250159 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03195
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K001338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO DAMAGE TO THE CATHETER OF THE DEVICE. HOWEVER, THROUGH FUNCTIONAL TESTING IT WAS REVEALED THAT A PINHOLE WAS PRESENT IN THE BALLOON MATERIAL. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED DEFECT OF BALLOON PINHOLE WAS CONFIRMED. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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 RX DILATATION BALLOON WAS USED DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, IT WAS REPORTED THAT THE BALLOON WAS ATTEMPTED TO BE INFLATED, BUT WAS UNSUCCESSFUL. IT WAS CONFIRMED THAT THE BALLOON HAD A LEAK DUE TO A PINHOLE IN THE BALLOON MATERIAL. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00545940 14304103

    Patients

    Seq Age Sex Outcome Treatment
    1