BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 974228 · Received April 17, 2007

    Report

    Report Number
    6000130-2007-00082
    Event Type
    Malfunction
    Date Received
    April 17, 2007
    Date of Event
    December 5, 2006
    Report Date
    April 9, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    k843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE GUIDEWIRE WAS RECEIVED STUCK INSIDE OF A MEDI-TECH CATHETER. THE CATHETER WAS REMOVED. THE OD OF THE GUIDEWIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. VISUAL INSPECTION OF THE WIRE REVEALED BENDS AT 4CM, 6.5CM, AND KINKS AT 80CM, 149.5CM, 182CM, 192CM, AND 230CM, FROM THE DISTAL TIP. THE COATING WAS MISSING AT THE KINKED AREAS FROM THE INTERACTION WITH THE CATHETER. THE CATHETER WAS RECEIVED WITH A DETACHED DISTAL SECTION OF ABOUT 6 CM, WITH THE GUIDEWIRE STILL GOING THROUGH BOTH PIECES OF THE CATHETER. THERE WERE NO OTHER VISIBLE KINKS ON THE CATHETER. THERE WAS SOME RESISTANCE TO REMOVE THE GUIDEWIRE DUE TO THE KINKS. THE BENDS AND KINKS RESULTED IN THE REPORTED DIFFICULTY RETRACTING THE UNIT FROM THE CATHETER. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED PER THE REQUIREMENTS OF THE MANUFACTURING PROCEDURE AND FOUND TO MEET ALL REQUIREMENTS. THE REPORTED LOT#8183296, HAS NOT BEEN INVOLVED IN ANY ADDITIONAL COMPLAINTS. THE ROOT CAUSE OF THE PROCEDURAL DIFFICULTIES CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS APPROVED 09-APR-2007. IT WAS REPORTED THAT DURING AT TIPS (PI PROCEDURE OF DILATION OF TRANSJUGULAR INTRAHEPTIC PORTOSYSTEMIC SHUNT) TREATMENT PROCEDURE, GUIDEWIRE REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE CUSTOMER STATED THAT, "DURING A DILATION, IMPOSSIBLE TO REMOVE BLUE MARS CATHETER FROM THE GUIDEWIRE 0.035.'' NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION NA 8183296

    Patients

    Seq Age Sex Outcome Treatment
    1 *