BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2112974 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03863
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED BALANCE MIDDLEWEIGHT 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. THERE WERE OFFSET AND OVERLAPPING INTERMEDIATE COILS SPORADICALLY, PROXIMAL TO THE CENTER SOLDER. THERE WAS A BEND IN THE TIP, PROXIMAL TO THE TIPBALL. THESE NOTED OFFSET AND OVERLAPPING INTERMEDIATE COILS AND BEND IN THE TIP ARE CONSISTENT WITH INTERACTION WITH THE LESION ANATOMY AND/OR OTHER DEVICE AS THERE WAS NO DAMAGE OF THESE TYPE NOTED DURING INSPECTION PRIOR TO USE. ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE WAS SEPARATED AT THE DISTAL END OF THE HYPOTUBE. THERE WAS CORE VISIBLE IN THE HYPOTUBE AT THE SEPARATION. THE SEPARATED PORTION WAS RETURNED. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF THE GUIDE WIRE SUGGESTS THAT THE CORE FAILURE MAY BE ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. IT WAS NOTED THAT THERE WAS CORE EXTENDING OUT THE HYPOTUBE, INDICATING THE HYPOTUBE WAS PROPERLY ATTACHED TO THE CORE. A HYPOTUBE BEING OVER PULLED OR OVER BENT WOULD REQUIRE IT TO BE TRAPPED WITHIN THE LESION ANATOMY AND/OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO CAUSE A SEPARATION. GUIDE WIRES ARE FRAGILE AND IT IS POSSIBLE THAT DURING REMOVAL OF THE WIRE FROM THE DISPENSER HOOP, PREPARATION OF THE GUIDE WIRE FOR USE, THAT A BEND COULD OCCUR THAT WOULD LATER FRACTURE. IN THIS CASE, DURING INSPECTION PRIOR TO USE, A SLIGHT BEND WAS NOTICED WHICH COULD HAVE CONTRIBUTED TO THE REPORTED SEPARATION AND IT SHOULD BE NOTED IN THE INSTRUCTIONS FOR USE PRECAUTIONS SECTION: GUIDE WIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE GUIDE WIRE CAREFULLY FOR BENDS, KINKS, OR OTHER DAMAGE. DO NOT USE DAMAGES GUIDE WIRES. USING A DAMAGED GUIDE WIRE MAY RESULT IN VESSEL DAMAGE AND/OR INACCURATE TORQUE RESPONSE. IT IS POSSIBLE THAT THE USE OF THE DAMAGED GUIDE WIRE COULD HAVE CONTRIBUTED TO THE REPORTED GUIDE WIRE SEPARATION. REPORTEDLY, THE SEPARATED PORTION WAS ABLE TO BE RETRIEVED FROM THE ANATOMY USING A BALLOON CATHETER AND NOTHING REMAINED IN THE PATIENT. THE LOT HISTORY RECORD WAS REVIEWED. THERE ARE NO NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED FOR THIS LOT. THE REPORTED GUIDE WIRE SEPARATION APPEARS TO BE RELATED TO USER ERROR FOR USING A DAMAGED GUIDE WIRE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER BEING LOADED INTO THE DISPENSER, PERFORMS NON-DESTRUCTIVE HYPOTUBE JUNCTION PULL TEST AND PERFORMS 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 DURING DEVICE UNPACKAGING FOR A PROCEDURE, THE GUIDE WIRE WAS SLIGHTLY BENT BUT PREPARED AND USED IN THE PROCEDURE; HOWEVER, THE GUIDE WIRE SEPARATED INTO 2 PIECES IN THE ANATOMY. THE GUIDE WIRE CROSSED THE TARGET LESION WITHOUT INCIDENT; A BALLOON FOR PRE-DILATATION, A STENT DEVICE AND AFTER STENT PLACEMENT A BALLOON FOR POST-DILATATION WERE ADVANCED OVER THE GUIDE WIRE WITHOUT ISSUE. AFTER POST-DILATATION IT WAS NOTED THAT THE GUIDE WIRE WAS NOT RESPONDING/NOT REACTING AND AN X-RAY REVEALED THE GUIDE WIRE WAS SEPARATED INSIDE THE GUIDING CATHETER. THE FRAGMENT WAS REMOVED FROM THE ANATOMY BY USING A BALLOON. THE UNSPECIFIED BALLOON WAS ADVANCED INTO THE GUIDING CATHETER AND INFLATED TO SNARE THE GUIDE WIRE FRAGMENT WHILE INSIDE THE GUIDING CATHETER. NOTHING REMAINED IN PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO ADDITIONAL INFORMATION 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 1030371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention