BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 2002937 · Received February 28, 2011

    Report

    Report Number
    2024168-2011-01238
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. RESISTANCE AND INABILITY TO RETRACT BETWEEN THE GUIDE WIRE AND THE COMPETITORS LEAD CAN OCCUR DUE TO, BUT IS NOT LIMITED TO, CONDITION OF THE GUIDE WIRE, PATIENT ANATOMICAL MORPHOLOGY, WIRE MANIPULATION TECHNIQUE, AND/OR LESION CHARACTERISTICS. IN SOME INSTANCES, SUCH AS DURING MANIPULATION WHERE HEAVY TORQUING AND/OR PUSHING/PULLING IS REQUIRED, THE CLEARANCE BETWEEN THE WIRE AND THE OTHER DEVICE CAN BE REDUCED TO AN UNDESIRABLE LEVEL AND CAUSE RESISTANCE BETWEEN DEVICES. SINCE IT WAS REPORTED THAT THE BMW GUIDE WIRE WAS INSERTED FOR USE IN A VENTRICULAR PACER LEAD, IT SHOULD BE NOTED THAT THE BMW GUIDE WIRE INSTRUCTIONS FOR USE STATES IN THE INTENDED USE SECTION: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE USE OF THE BMW GUIDE WIRE TO PLACE A NON-ABBOTT PACER LEAD COULD HAVE CONTRIBUTED TO THE REPORTED INABILITY TO POSITION AND RETRACT THE GUIDE WIRE FROM THE LEAD AS THE DEVICES WERE NOT INSERTED IN A VESSEL. THE NON-ABBOTT PACER LEAD AND THE GUIDE WIRE WERE NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. THE REPORTED RESISTANCE, AND INABILITY TO RETRACT THE DEVICE APPEARS TO BE RELATED TO USER TECHNIQUE AND THE OPERATIONAL CONTEXT OF THE PROCEDURE AS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING VISUALLY INSPECTS 100% OF THE GUIDE WIRE TIP AFTER LOADING INTO THE DISPENSER, AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST BALANCE MIDDLE-WEIGHT (BMW) GUIDE WIRE WAS INSERTED FOR USE IN VENTRICULAR PACER LEADS. THE BMW WAS UNABLE TO PASS THROUGH THE NON-ABBOTT 4 FRENCH LEAD AND WAS THEN UNABLE TO BE REMOVED FROM THE NON-ABBOTT LEAD. THE PHYSICIAN CUT THE BMW AT THE TRANSITION POINT, AROUND 10 TO 12 CM FROM THE TIP. BOTH PIECES OF THE BMW GUIDE WIRE WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT. A SECOND BMW WIRE WAS INSERTED AND MET RESISTANCE. IT ALSO WOULDN'T PASS, BUT WAS ABLE TO BE PULLED OUT OF THE LEAD. AFTERWARDS, THE PHYSICIAN RAN HIS FINGERS ALONG THE GUIDE WIRE AND FELT MULTIPLE BUMPS ON IT. A WHISPER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0102871

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention OTHER: ST. JUDE 4 FRENCH VENTRICULAR LEAD