BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 2241066 · Received September 9, 2011

    Report

    Report Number
    3005099803-2011-03007
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE BALLOONS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-03006 ADDRESSES THE FIRST CRE BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2011-03007 ADDRESSES THE SECOND CRE BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT TWO CRE BALLOON DILATATION CATHETERS WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST BALLOON WAS ATTEMPTED TO BE INFLATED, HOWEVER DIFFICULTY WAS EXPERIENCED AND THE BALLOON DID NOT INFLATE EVENLY. SPECIFICALLY, THE TOP OF THE BALLOON INFLATED WHILE THE PORTION OF THE BALLOON IN THE STRICTURE DID NOT INFLATE TO THE MAXIMUM DESIRED SIZE. ACCORDING TO THE NURSE, THE BALLOON LOOKED MUSHROOM SHAPED. THE BALLOON WAS REMOVED FROM THE PATIENT. THE SECOND BALLOON WAS ATTEMPTED TO BE INFLATED AND THE SAME ISSUES OCCURRED. THIS BALLOON WAS ALSO REMOVED FROM THE PATIENT. THERE WERE NO VISIBLE LEAKS OR HOLES NOTED IN EITHER BALLOON OR KINKS IN THE CATHETER OF EITHER DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER, NON-BSC 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 FINE.

    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 M00558450 14416509

    Patients

    Seq Age Sex Outcome Treatment
    1