BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R.E. BALLOON DILATATION CATHETER

    MDR report key: 1082634 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01244
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHO-GASTRO DILATATION (EGD) PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE ESOPHAGUS. THE CRE 15MM X 18MM BALLOON CATHETER WAS ADVANCED TO THE LESION AND SUCCESSFULLY DILATED THE LESION. THE NUMBER OF INFLATIONS AND TO WHAT ATMS THE BALLOON REACHED ON EACH INFLATION IS UNKNOWN. UPON ATTEMPTING TO WITHDRAW THE BALLOON CATHETER THROUGH THE ENDOSCOPE, THE BALLOON "HUNG UP INSIDE THE SCOPE CHANNEL" AND THE "CATHETER STRIPPED LOOSE OF THE BALLOON, LEAVING THE BALLOON STUCK IN THE SCOPE CHANNEL AND UN-RETRIEVABLE". THE PROCEDURE WAS COMPLETED USING ANOTHER ENDOSCOPE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R.E. BALLOON DILATATION CATHETER KNQ - BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC M0058370 0011262605

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS 180 SCOPE