BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2690823 · Received August 10, 2012

    Report

    Report Number
    3005099803-2012-03483
    Event Type
    Malfunction
    Date Received
    August 10, 2012
    Date of Event
    July 18, 2012
    Report Date
    July 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K NUMBER IS K112994.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS OVER (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A DILATATION PROCEDURE IN THE PROXIMAL ESOPHAGUS ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, AFTER THE BALLOON WAS INFLATED TO 12MM SUCCESSFULLY THE NURSE REPORTED TO HAVE ISSUES DEFLATING THE BALLOON AND THE BALLOON COULD NOT FULLY DEFLATE. THE BALLOON WAS REMOVED AND ANOTHER CRE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2012 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A DILATATION PROCEDURE IN THE PROXIMAL ESOPHAGUS ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, AFTER THE BALLOON WAS INFLATED TO 12MM SUCCESSFULLY THE NURSE REPORTED TO HAVE ISSUES DEFLATING THE BALLOON AND THE BALLOON COULD NOT FULLY DEFLATE. THE BALLOON WAS REMOVED AND ANOTHER CRE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE 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¿ WIREGUIDED BALLOON DILATOR KNQ BOSTON SCIENTIFIC - CORK M00558690

    Patients

    Seq Age Sex Outcome Treatment
    1