BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 2180069 · Received July 27, 2011

    Report

    Report Number
    3005099803-2011-02588
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    April 28, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. 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 THAT THE BALLOON DID NOT COMPLETELY DEFLATE COULD NOT BE CONFIRMED. HOWEVER, BALLOON INFLATION AND DEFLATION 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A GASTROSCOPY AND GASTRIC DILATATION PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DILATATION WAS COMPLETED WITH THIS DEVICE AND THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S ANATOMY; HOWEVER, WHEN ATTEMPTING WITHDRAWAL, THE BALLOON GOT STUCK IN THE WORKING CHANNEL OF THE GASTROSCOPE. IT WAS REPORTED THAT THE BALLOON DID NOT COMPLETELY DEFLATE. THE SCOPE AND THE BALLOON WERE REMOVED FROM THE PATIENT TOGETHER AND THE PROCEDURE WAS STOPPED TO FLATTEN THE BALLOON BY HAND IN ORDER TO REMOVE IT FROM THE GASTROSCOPE. NO VISIBLE ISSUES WERE NOTED TO THE DEVICE. THE GASTROSCOPY WAS RESTARTED AND PERFORMED TO CHECK THAT THE PATIENT WAS OKAY. 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 M00558360 13868322

    Patients

    Seq Age Sex Outcome Treatment
    1