BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 2250185 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03204
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. THEREFORE, A DEVICE EVALUATION HAS NOT BEEN PERFORMED AND THE REPORTED MALFUNCTION OF HOLE IN BALLOON MATERIAL COULD NOT BE CONFIRMED. HOWEVER, BALLOON INFLATION ISSUES CAN OCCUR DUE TO PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE BALLOONS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-03204 ADDRESSES THE FIRST BALLOON, AND MANUFACTURER REPORT # 3005099803-2011-03205 ADDRESSES THE SECOND BALLOON.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE BALLOON DILATATION CATHETERS WERE USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON A (B)(6) MALE PATIENT IN THE WEEK OF (B)(6), 2011 (EXACT EVENT DATE AND PATIENT WEIGHT ARE UNKNOWN).ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOONS WERE ATTEMPTED TO BE INFLATED IN THE ESOPHAGUS, HOWEVER EACH BALLOON COULD NOT BE INFLATED. IT LOOKED LIKE THERE WERE SMALL HOLES IN THE BALLOONS. IT WAS CONFIRMED THAT NEITHER BALLOON BURST. A THIRD CRE BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE.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 OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558380 14187703

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR