BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 2122334 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-01973
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS OLD. 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), 2011 THAT A CRE BALLOON DILATATION CATHETER WAS TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, WHEN REMOVING THE DEVICE FROM THE PACKAGING, IT WAS OBSERVED THAT THE DISTAL TIP OF THE BALLOON WAS BENT AND THE BALLOON APPEARED TO BE WRINKLED. IT WAS ALSO REPORTED THAT THE LUMEN INSIDE THE BALLOON WAS KINKED. THE DEVICE WAS NEVER INFLATED OR ATTEMPTED TO BE USED IN THE PATIENT. IT WAS CONFIRMED THAT NO VISIBLE ISSUES WERE NOTED TO THE PACKAGING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 BALLOON DILATATION CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558370 14241247

    Patients

    Seq Age Sex Outcome Treatment
    1