BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PULMONARY BALLOON DILATATION CATHETER

    MDR report key: 1160029 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04504
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KTI
    PMA / PMN Number
    K023337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED THAT RELATE TO THE REPORTED MALFUNCTION. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS REPORTED FOR THE SAME LOT.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A CRE PULMONARY BALLOON DILATATION CATHETER DEVICE WAS USED. ACCORDING TO THE COMPLAINANT, THE BALLOON BURST DURING INFLATION WHILE INSIDE THE PATIENT. NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY BALLOON DILATATION CATHETER 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 "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE PULMONARY BALLOON DILATATION CATHETER KTI BOSTON SCIENTIFIC CORK LTD. M00550340 0011602482

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK