BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE FIXED WIRE

    MDR report key: 11735010 · Received April 27, 2021

    Report

    Report Number
    3005099803-2021-01905
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    UDI-DI
    08714729202011
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT: (B)(6) KG. (B)(4). 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 THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627689 CRE FIXED WIRE DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC CORPORATION M00558380 0026110046 08714729202011

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR