BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 1882117 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04554
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A DILATATION PROCEDURE PERFORMED ON (B)(6), 2010 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST IN THE ESOPHAGUS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 GOOD. ATTEMPTS TO OBTAIN FURTHER PATIENT AND PROCEDURE INFORMATION SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558390 13545801

    Patients

    Seq Age Sex Outcome Treatment
    1