BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ GUIDE WIRE

    MDR report key: 970560 · Received December 28, 2007

    Report

    Report Number
    6000111-2007-00015
    Event Type
    Injury
    Date Received
    December 28, 2007
    Date of Event
    December 2, 2007
    Report Date
    December 5, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT WAS DISPOSED OF; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION.

    Description of Event or Problem · 1

    NOTE:THIS REPORT PERTAINS TO THE FIRST OF FOUR DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MANUFACTURER REPORT #6000043-2007-00146, 6000043-2007-00147, 6000043-2007-00148 FOR THE OTHER RELATED DEVICES. ON DECEMBER 5, 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR VL STENT WAS USED IN A BILATERAL STENT PLACEMENT PROCEDURE ON A FEMALE, OCCURRING ON THREE DAYS EARLIER. THE INDICATION FOR THE PROCEDURE WAS OCCLUDED URETERS. THE PT'S WEIGHT IS UNK. ACCORDING TO THE COMPLAINANTT, THE PT'S URETERS "WERE NOT IN GOOD CONDITION TO BEGIN WITH". THE CONTOUR STENT WAS PLACED ON THE LEFT SIDE USING A BSC AMPLATZ WIRE (CATALOGUE #46-523 LOT #9428227). DURING REMOVAL OF THE WIRE, THE PHYSICIAN ENCOUNTERED DIFFICULTY CAUSING HIM TO USE EXTREME FORCE TO REMOVE THE WIRE. CONSEQUENTLY, THE STENT BUCKLED AND THE WIRE UNCOILED. THE PHYSICIAN THEN USED A BSC BENTSON-TYPE WIRE (#620-125 LOT# 01770747) TO PUSH THE STENT BACK INTO THE KIDNEY. ACCORDING TO THE COMPLAINANT, WHEN PACING THE STENT ON THE RIGHT SIDE, THE SAME EVENT OCCURRED. BY THIS TIME THE BLADDER WAS FULL OF BLOOD AND THE PHYSICIAN COULD NOT SEE THE URETERAL ORIFICE. ACCORDING TO THE PHYSICIAN, "THE PT HAD PROLONGED PROCEDURE AND LESS SATISFACTORY FINAL STENT POSITION DUE TO STENT PROBLEMS - SHE IS EXTREMELY ILL FROM HER HEMATOLOGICAL MALIGNANCY". THE COMPLAINANT ALSO INDICATED PT OUTCOME AS TRAUMA TO THE BLADDER AND URETERS AND PROLONGED ANAESTHETIC. THE PHYSICIAN INDICATED THAT THE BLOOD IN THE BLADDER WAS NOT RELATED TO THE EVENT, BUT RELATED TO THE PT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ GUIDE WIRE DQX BOSTON SCIENTIFIC CORP. M0066401040 0009428227

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization