BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN

    MDR report key: 1961496 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00291
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INDICATION FOR USE. EVALUATION SUMMARY: EVALUATION OF THE RETURNED HI TORQUE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE NOTED BLOOD AND CONTRAST ON THE COILS WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE CORE EXHIBITED DETACHMENT FROM THE DISTAL END OF THE HYPOTUBE. ANALYSIS ALSO NOTED THAT THERE WAS NO CORE VISIBLE IN THE HYPOTUBE AT THE SEPARATION INDICATING THAT THE HYPOTUBE WAS NOT PROPERLY ATTACHED TO THE CORE. A HYPOTUBE BEING OVER PULLED AND POSSIBLY NOT ENOUGH ADHESIVE FROM MANUFACTURING COULD CONTRIBUTE TO THE REPORTED GUIDE WIRE SEPARATION. ALTHOUGH REQUESTED, ANATOMICAL INFORMATION WAS NOT PROVIDED. REPORTEDLY, WHEN THE PACEMAKER LEAD (THE BMW WAS BEING USED TO FACILITATE PLACEMENT) WAS PULLED BACK, THE SEPARATED PORTION WAS RETRIEVED AND REMOVED FROM THE ANATOMY. ANALYSIS ALSO NOTED OFFSET AND OVERLAPPING INTERMEDIATE COILS 1 MM PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 6 MM WHICH IS CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY DURING THE PROCEDURE. THERE WAS A BEND IN THE CORE, 57 CM DISTAL TO THE SEPARATION WHICH IS CONSISTENT WITH PRODUCT HANDLING DURING PROCEDURAL ATTEMPTS TO REMOVE AND RETRIEVE THE GUIDE WIRE FROM THE ANATOMY AS NO DAMAGES WERE REPORTED DURING INSPECTION PRIOR TO USE. AS IT WAS REPORTED THAT THE GUIDE WIRE WAS USED WITH A PACEMAKER LEAD, IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) 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 (PTCA) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE SEM ANALYSIS RESULTS, THE REPORTED GUIDE WIRE SEPARATION APPEARS TO BE RELATED TO MANUFACTURING. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A "BI-VENTRICULAR" PROCEDURE THROUGH THE CORONARY SINUS THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE BECAME SEPARATED. DURING PULLING BACK OF THE LEAD WIRE, THE SEPARATED FRAGMENT WAS RETRIEVED AND REMOVED FROM THE ANATOMY. NONE OF THE DEVICE REMAINED IN THE ANATOMY. THERE WAS NO REPORTED PATIENT SEQUELA. ALTHOUGH REQUESTED, THERE WAS NO PATIENT INFORMATION OF AGE OR DATE OF BIRTH, GENDER, OR WEIGHT PROVIDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN GUIDE WIRE DQX AV-TEMECULA-CT 9011383

    Patients

    Seq Age Sex Outcome Treatment
    1