BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 1923412 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02708
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT 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 THE CORE AND SHAPING RIBBON WERE INTACT. THE ANALYSIS CONFIRMED THE REPORTED GUIDE WIRE SEPARATION AS THE CORE HAD SEPARATED AT THE PROXIMAL END OF THE HYPOTUBE. THERE WAS A CORE EXTENDING OUT OF THE HYPOTUBE. THERE WERE OFFSET AND OVERLAPPED TIP COILS, 8 MM PROXIMAL TO THE TIP BALL FOR A LENGTH OF .5 MM AND 1.8 CM PROXIMAL TO THE TIP BALL. THERE WERE FLATTENED TIP COILS 1.2 CM PROXIMAL TO THE TIP BALL FOR A LENGTH OF 1.5 MM. THERE WERE STRETCHED TIP COILS 1.6 CM PROXIMAL TO THE TIP BALL FOR A LENGTH OF .5 MM. SCANNING ELECTRON MICROSCOPE (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 OF 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 VESSEL OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO CAUSE A SEPARATION. IN THIS CASE, IT WAS REPORTED THAT DURING REMOVAL, THE GUIDE WIRE WAS CAUGHT IN THE VESSEL THAT COULD HAVE CONTRIBUTED TO THE GUIDE WIRE SEPARATION. GUIDE WIRES ARE FRAGILE AND IT IS POSSIBLE THAT DURING REMOVAL OF THE WIRE, A BEND COULD OCCUR THAT WOULD LATER FRACTURE. ALTHOUGH IT WAS REPORTED THAT THE ENTIRE GUIDE WIRE WAS SUCCESSFULLY SNARED, THE GUIDE WIRE BECOMING CAUGHT IN THE VESSEL WAS LIKELY THE RESULT OF THE REPORTED GUIDE WIRE SEPARATION. TO ENSURE THAT THIS TYPE OF GUIDE WIRE SEPARATION DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING INSPECTS 100% OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER AND PERFORMS A NON-DESTRUCTIVE HYPOTUBE JUNCTION PULL TEST. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. THE REPORTED GUIDE WIRE SEPARATION AND DIFFICULT TO REMOVE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE BUT THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING INSPECT 100% OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER AND PERFORMS A NON-DESTRUCTIVE HYPOTUBE JUNCTION PULL TEST. 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, DEVICE ANALYSIS REVEALED THAT THE DEVICE IS A BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE CORONARY SINUS, WHILE PULLING BACK THE BALANCE MIDDLEWEIGHT GUIDE WIRE, THE WIRE SEPARATED AND BECAME CAUGHT IN THE VESSEL. THE ENTIRE GUIDE WIRE WAS SUCCESSFULLY SNARED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A WHISPER GUIDE WIRE. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention