BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALANCE MIDDLEWEIGHT UNIVERSAL

    MDR report key: 8109842 · Received November 28, 2018

    Report

    Report Number
    8109842
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 16, 2018
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FROM URGENT CARE CENTER WITH C/O CHEST PAIN AND KNOWN ST ELEVATIONS IN LEADS II, III, AND AVF WITH DEEP ST DEPRESSION IN LEADS V1-V3. PATIENT TAKEN EMERGENTLY TO CARDIAC CATH LAB FOR PERCUTANEOUS INTERVENTION. EMERGENT CORONARY ANGIOGRAPHY SHOWED AN OCCLUDED RAMUS INTERMEDIUS VESSEL WHICH BIFURCATED INTO TWO LARGE BRANCHES. A 6F EBU 3.25 GUIDE CATHETER WAS USED TO ENGAGE THE LEFT MAIN TRUNK (LMT) OSTIUM, A BALANCED MIDDLE WEIGHT (BMW), LOT# 8060871 REF# 1009660, WAS NAVIGATED INTO THE DISTAL RAMUS. THE OCCLUDED SEGMENT OF THE ARTERY WAS DILATED WITH 2.0 X 12 MM MINI-TREK BALLOON. AS THE WIRE WAS LOCATED IN THE SMALLER SUPERIOR BRANCH OF THE RAMUS BIFURCATION, A SECOND BMW WIRE (LOT# 8100471 REF# 1009660) WAS INSERTED INTO THE LARGER INFERIOR BRANCH WITH THE INTENT OF STENTING OVER THE WIRE DIRECTED INTO THE INFERIOR BRANCH. THE RAMUS WAS STENTED WITH A 2.5 X 2 MM XIENCE SIERRA DES AND FLOW RESTORED. FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (PCI), THE CORONARY WIRES WERE REMOVED. ON PULLING BACK, THE JAILED SUPERIOR BMW WIRE RESISTANCE WAS ENCOUNTERED AND THE TIP OF THE WIRE WAS RETAINED IN THE STENT STRUTS. FOLLOWING PCI, THE PATIENT WAS CHEST PAIN FREE AND REMAINED HEMODYNAMICALLY STABLE. THE PATIENT WAS TRANSFERRED TO A TERTIARY CENTER FOR MANAGEMENT AND POTENTIAL TREATMENT OF THE RETAINED WIRE. PER HOSPITAL, THE MANUFACTURER'S QUALITY DEPARTMENT IS AWARE OF THE EVENT AND HAVE REQUESTED ADDITIONAL INFORMATION ABOUT THE DEVICE. A CONTAINER FOR RETURNING THE DEVICE WILL BE REQUESTED FROM ABBOTT FOR RETURN OF THE DEVICE TO THE MANUFACTURER'S QUALITY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949687 BALANCE MIDDLEWEIGHT UNIVERSAL WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 8060871, 8100471

    Patients

    Seq Age Sex Outcome Treatment
    1 20440 DA