BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PULMONARY BALLOON DILATATION CATHETER

    MDR report key: 1800432 · Received August 16, 2010

    Report

    Report Number
    3005099803-2010-03420
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KTI
    PMA / PMN Number
    K023337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. PATIENT IS OVER 18 YEARS OLD. THE COMPLAINANT REPORTED THAT THE EVENT OCCURRED ON EITHER (B)(6), 2010 OR (B)(6), 2010. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CRE PULMONARY BALLOON DILATATION CATHETER WAS USED DURING A BRONCHOSCOPY PROCEDURE (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON POPPED IN THE TRACHEA OF THE PATIENT. NO PIECES OF THE DEVICE DETACHED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY BALLOON DILATATION CATHETER. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE PULMONARY BALLOON DILATATION CATHETER BRONCHOSCOPE ACCESSORY KTI BOSTON SCIENTIFIC - CORK M00550350

    Patients

    Seq Age Sex Outcome Treatment
    1