BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1930780 · Received December 16, 2010

    Report

    Report Number
    2024168-2010-02788
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    AV-BARCELONETA
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED BALANCE MIDDLEWEIGHT GUIDE WIRE CONFIRMED THE REPORTED STRETCHED COILS AS THE ENTIRE LENGTH OF THE TIP COILS WERE STRETCHED. ANALYSIS ALSO NOTED THE SHAPING RIBBON WAS SEPARATED, 2.5 CM DISTAL TO THE CENTER SOLDER. THE REMAINING 5 MM OF THE SHAPING RIBBON WAS STILL INTACT WITH THE TIP BALL. THE CORE WAS IN A PIGTAIL SHAPED AT THE CENTER SOLDER FOR A LENGTH OF 5 CM PROXIMALLY. SCANNING ELECTRON MICROSCOPE ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE SHAPING RIBBON FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD. FOR THE WIRE TO FAIL IN THIS MANNER THE GUIDE WIRE WOULD HAVE BEEN OVER BENT BY PUSHING OR PULLING OR OVER TORQUED BY TURNING AND WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. THE REPORTED STRETCHED COILS AND THE NOTED PIGTAIL SHAPED CORE ARE LIKELY THE RESULT OF THE GUIDE WIRE TIP SEPARATION. PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN THE PRODUCTS CAN ALL BE FACTORS. THE VESSEL WAS DESCRIBED AS MODERATELY TORTUOUS WHICH COULD HAVE CONTRIBUTED TO THE GUIDE WIRE TIP SEPARATION. ANY ATTEMPTS TO MOVE THE GUIDE WIRE IN A TRAPPED STATE COULD HAVE THEN CAUSED THE NOTED TIP SEPARATION. PER THE DEVICE INSTRUCTIONS FOR USE, DO NOT: PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. ALLOW THE GUIDE WIRE TIP TO REMAIN IN A PROLAPSED CONDITION. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE. IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. OVERALL, THE REPORTED STRETCHED COILS AND THE NOTED GUIDE WIRE TIP SEPARATION AND PIGTAIL SHAPED CORE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS A NON DESTRUCTIVE TIP PULL TEST ON EACH WIRE, AND PERFORMS 100% VISUAL INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    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 THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE BECAME UNRAVELED AT THE TIP DURING REMOVAL OF THE DEVICE FROM THE PATIENT AFTER IT WAS UNABLE TO CROSS THE MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BMW DID NOT SEPARATE AND WAS COMPLETELY REMOVED FROM THE PATIENT. ANOTHER BMW WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE EVALUATION FOUND THAT THE SHAPING RIBBON WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX AV-BARCELONETA 0082671

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR GUIDE WIRE: BALANCE MIDDLEWEIGHT