BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTERTOME

    MDR report key: 1222872 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06106
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ABNORMAL APPEARANCE OF TIP - ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREP OF A HYDRATOME RX SPHINCTEROTOME DEVICE, THE DISTAL TIP "DID NOT APPEAR TO BE NORMAL AND HAD A JAGGED EDGE." ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME RX SPHINCTEROTOME 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 HYDRATOME RX SPHINCTERTOME KNS BOSTON SCIENTIFIC CORPORATION M00583040 11942498

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK