BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 1898672 · Received January 24, 2011

    Report

    Report Number
    2024168-2010-02337
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    August 23, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED; HOWEVER, THE INVESTIGATION IS NOT YET COMPLETE. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE 3.5 X 12 MM OTW XIENCE (1009548-12, 9070961) AND 3.0 X 15 MM OTW XIENCE (1009547-15, 0012761) ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED GUIDE WIRE FOUND BLOOD VISIBLE ON THE CORE AND COILS, WHICH IS CONSISTENT WITH THE DEVICE BEING USED OR HANDLED DURING A PROCEDURE. THE INTERMEDIATE COILS WERE PUSHED DISTALLY FROM THE PROXIMAL SOLDER AND THE TIP COILS WERE PUSHED DISTALLY FROM THE CENTER SOLDER. THE TIP WAS TUGGED WHICH CONFIRMED THE CORE AND SHAPING RIBBON WERE INTACT. ANALYSIS ALSO NOTED MULTIPLE CLEAR BLUE FIBERS ON THE PROXIMAL END OF THE TIP COILS, WHICH WERE SENT FOR FURTHER CHEMICAL ANALYSIS TO DETERMINE THE ORIGIN OF THE FIBERS. THE RESULTS INDICATE THAT THE FIBER SCANS RESEMBLE EACH OTHER AS WELL AS THE POLYESTER USED FOR GOWNS STITCHES, KNIT WIPES, BUNNY GOWNS, HOWEVER, THE ORIGIN IS UNKNOWN. DAMAGED TO THE GUIDE WIRE CAN OCCUR DUE TO, BUT IS NOT LIMITED TO, MANUFACTURING, DAMAGE DURING SHIPPING, REMOVAL TECHNIQUE FROM THE DISPENSER, AND/OR HANDLING PRIOR, DURING OR AFTER THE PROCEDURE. THE GUIDE WIRE WAS INITIALLY RETURNED FROZEN INSIDE THE SDS, WHICH WOULD INDICATE THE WIRE WAS USED DURING THE PROCEDURE. THE COILS STRETCHING AWAY FROM THE PROXIMAL AND CENTER SOLDERS INDICATE THAT A PULLING FORCE MAY HAVE APPLIED AT THOSE LOCATIONS, HOWEVER, IT IS UNKNOWN WHEN THIS COULD HAVE OCCURRED SINCE NO INFORMATION WAS PROVIDED. IT IS ALSO POSSIBLE THAT THE GUIDE WIRE MAY HAVE BEEN WIPED DOWN USING A WIPE AFTER THE PROCEDURE, WHICH COULD HAVE CAUSED THE COILS TO STRETCH DISTALLY AND COULD HAVE LEFT FIBERS ON THE COILS. IN ORDER TO ENSURE THE DAMAGE FOUND DURING ANALYSIS IS NOT A RESULT OF A PRODUCT DEFICIENCY, ALL PRODUCTS ARE SUBJECTED TO A 100% VISUAL AND DIMENSIONAL INSPECTION BY MANUFACTURING, AND PERFORMS A 100% OUTER DIAMETER INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE DAMAGE FOUND DURING ANALYSIS AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. IN THIS CASE, WITH THE LIMITED INFORMATION AVAILABLE, A CONCLUSIVE CAUSE FOR THE STRETCHED COILS AND FIBERS ON THE WIRE FOUND DURING ANALYSIS COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT CROSS. IT IS UNK IF ANYTHING CROSSED. NO PT EFFECTS WERE REPORTED. A 3.0 X 15 OTW XIENCE AND A BMW UNIVERSAL II GUIDE WIRE HAVE BEEN RETURNED AND ADDED TO THIS EVENT. NO INFORMATION IS AVAILABLE REGARDING THE ISSUE WITH THESE TWO DEVICES. REPORTEDLY, THERE WAS NO PT INJURY. BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2010; THE BMW UNIVERSAL II GUIDE WIRE WAS NOTED TO HAVE FIBERS ON THE DEVICE. THERE IS NO INFORMATION AT THIS TIME TO INDICATE WHERE THE FIBERS CAME FROM; THEREFORE, THIS DEVICE WILL BE CONSERVATIVELY FILED AS FOREIGN MATERIAL ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR - CARDIAC THERAPIES NA 0061571

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT 3.5 X 12 MM OTW XIENCE| 3.0 X 15 MM OTW XIENCE (B)(4)| 3.0 X 15 MM OTW XIENCE (1009547-15)