BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 2192085 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03130
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE LOT NUMBER OF THE RETURNED LABELS MATCHED THE EXPECTED LOT NUMBER, CONFIRMING THAT THE CORRECT COMPLAINT DEVICE WAS RECEIVED FOR INVESTIGATION. THE FOLLOWING WAS OBSERVED: THE TWO FLAPS OF HUB ROTATOR WERE DAMAGED. THE UNIT WAS ABLE TO CONNECT INTO MDU SYSTEM PROPERLY. THE HUB O-RING WAS NOT IN PROPER PLACE WHEN THE DEVICE WAS RECEIVED. ONE HUB WING WAS BENT WHEN THE DEVICE WAS RECEIVED. THE MALE/FEMALE LUER CONNECTION WAS DETACHED AND THE IMAGING CORE WAS OUTSIDE OF THE SHEATH ASSEMBLY WHEN RECEIVED. THE GUIDEWIRE WAS STUCK INSIDE THE SHEATH ASSEMBLY WHEN RECEIVED. THE GUIDEWIRE EXIT PORT WAS LIFTED 1.0MM AND RIPPED 1.0MM LONG. THE SHEATH ASSEMBLY WAS STUCK INSIDE THE GUIDE CATHETER. IT WAS OBSERVED THAT THERE IS A STENT PRODUCT TANGLED AROUND THE DISTAL TIP SHEATH ASSEMBLY. IMAGING CORE WIND UP IN THE HUB AND TELESCOPE ASSEMBLY WAS OBSERVED DURING VISUAL ANALYSIS. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING VISUAL OR FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE OBSERVED DAMAGE TO THE GUIDEWIRE EXIT PORT, GUIDEWIRE STUCK IN SHEATH, SHEATH STUCK IN GUIDE CATHETER, MALE/FEMALE LUER DISCONNECT, AS WELL AS THE REPORTED EVENT DESCRIPTION. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749390140 14310447

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: PROMUS 2.5X8MM| BALLOON CATHETER: HIRYU| INFLATION DEVICE: ENCORE| GUIDE WIRE: RUNTHROUGH| GUIDE CATH: MACH1