BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2171655 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05067
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND NO BLOOD VISIBLE; HOWEVER, THERE WAS CONTRAST ON THE COILS WHICH IS CONSISTENT WITH PRODUCT HANDLING OUTSIDE OF THE DISPENSER COIL. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE AND SHAPING RIBBON WERE INTACT. THE DISTAL END OF THE SHAPING RIBBON, 8 MM FROM THE TIP BALL WAS BENT IN A HOOK SHAPE. THE CORE WAS BENT, 1.5 CM PROXIMAL AND 5 MM DISTAL TO THE CENTER SOLDER. THE TIP COILS WERE STRETCHED FROM THE CENTER SOLDER FOR A LENGTH OF 1 MM. THE PROXIMAL END OF THE SHAPING RIBBON LESS THAN .5 MM IN LENGTH WAS BENT AND PROTRUDING THROUGH THE INTERMEDIATE COILS, 3 MM PROXIMAL TO THE CENTER SOLDER. THERE WERE MULTIPLE OFFSET INTERMEDIATE COILS 3 MM PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 2.5 CM. THESE NOTED DAMAGES WERE NOT REPORTED IN THE INCIDENT INFORMATION AND LIKELY OCCURRED DURING HANDLING, PACKING, AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. MISLABELING CAN OCCUR DUE TO, BUT NOT LIMITED TO MIX-UP DURING MANUFACTURING OR PRODUCT MIX-UP AT THE ACCOUNT OR LABEL PRINTING ERROR. IN THIS CASE, ANALYSIS OF THE RETURNED PRODUCT COULD NOT CONFIRM THE REPORTED J SHAPED TIP AS THE TIP WAS NOT MEASURED WITH A J SHAPED FIXTURE DUE TO THE TIP BEING BENT IN A HOOK SHAPE. IN ORDER TO ENSURE THAT THIS DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER AND INSPECTS THE GUIDE WIRE POUCH LABELS. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. A CONCLUSIVE CAUSE FOR THE REPORTED MISLABELING COULD NOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NON-CONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY A QUERY OF THE COMPLAINT HANDLING DATA BASE FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS. IN SUMMARY, BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UN-PACKAGING OF THE BMW GUIDE WIRE, IT WAS OBSERVED THAT THE GUIDE WIRE TIP WAS CURVED. IT WAS NOTED THAT THE TIP WAS J-SHAPED; HOWEVER, THE LABEL WAS FOR A STRAIGHT TIP. THERE WAS NO PATIENT INVOLVEMENT, AND A NEW BMW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 1012471

    Patients

    Seq Age Sex Outcome Treatment
    1