BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WIRES

    MDR report key: 560283 · Received December 16, 2004

    Report

    Report Number
    6000130-2004-00212
    Event Type
    Injury
    Date Received
    December 16, 2004
    Date of Event
    November 24, 2004
    Report Date
    November 24, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PTCA/STENTING TREATMENT PROCEDURE, THE DISTAL TIP OF THE PT2 MODERATE SUPPORT GUIDEWIRE DETACHED FROM THE WIRE AND EMBOLIZED INTO THE DISTAL POSTERIOR LATERAL BRANCH ARTERY WITH NO IMMEDIATE PT COMPLICATIONS. THE WIRE WAS USED SUCCESSFULLY FOR THE STENTING OF TWO LESIONS IN THE PROXIMAL AND MID CIRCUMFLEX ARTERY. THE SAME WIRE WAS THEN ADVANCED DISTALLY INTO THE POSTERIOR DESCENDING ARTERY (PDA) OF THE DISTAL RIGHT CORONARY ARTERY. A SECOND PT2 MODERATE SUPPORT GUIDEWIRE WAS PLACED INTO THE POSTERIOR LATERAL BRANCH (PLB). A TAXUS 2.5/20 MM STENT WAS DEPLOYED ACROSS THE PDA/PLB BIFURCATION. THE SECOND PT2 GUIDEWIRE WAS REMOVED FROM THE PLB AND THE ORIGINAL PT2 GUIDEWIRE WAS ADVANCED THROUGH THE STENT STRUTS INTO THE PLB. THE STENT DELIVERY SYSTEM BALLOON CATHETER WAS ADVANCED INTO THE PLB AND INFLATED. WHEN THE BALLOON AND PT2 GUIDEWIRE WERE REMOVED FROM THE PLB, THE DISTAL TIP OF THE PT2 GUIDEWIRE FRACTURED AND EMBOLIZED INTO A DISTAL BRANCH OF THE PLB. A BRIEF ATTEMPT WAS MADE TO RETRIEVE THE WIRE TIP USING A MICROVENA 2.0 MM EV3 SNARE, AND A SMALL ACS VOYAGER MR 2.0/8 MM BALLOON CATHETER. THESE RETRIEVAL ATTEMPTS WERE NOT SUCCESSFUL, LEAVING THE DISTAL TIP OF THE PT2 MODERATE SUPPORT GUIDEWIRE EMBOLIZED DISTALLY. THE PT REMAINED PAIN FREE AND HEMODYNAMICALLY STABLE, SO THE PROCEDURE WAS CONCLUDED. THE CURRENT PT STATUS IS LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES PT2 PTCA GUIDEWIRE DQX BOSTON SCIENTIFIC PT2 MODERATE SUPPORT 185CM STR, 5-PACK 6880375

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R