BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE WITH HYD

    MDR report key: 1163095 · Received September 16, 2008

    Report

    Report Number
    2024168-2008-00808
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE GUIDEWIRE WAS RETURNED WITH NO BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE ON THE COILS. THE SHAPING RIBBON WAS SEPARATED, 8 MM PROXIMAL TO THE TIPBALL. THE SHAPING RIBBON WAS TWISTED, 2.1 CM DISTAL TO THE CENTER SOLDER FOR A LENGTH OF 1 MM. THE TIP COILS WERE PUSHED DISTAL FROM THE CENTER SOLDER FOR A LENGTH OF 31.8 CM. THERE WAS A KINK IN THE TIP, 1 MM PROXIMAL TO THE TIPBALL. THERE WERE OFFSET INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 2.3 CM. DURING ANALYSIS THE TIP COILS GOT SEPARATED 1.1 CM DISTAL TO THE CENTER SOLDER. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDEWIRE. THE GUIDEWIRE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PROD PERF ENGINEERING REVIEWED THE INCIDENT INFO AND THE ANALYSIS OF THE RETURNED GUIDEWIRE. ANALYSIS FOUND THE DAMAGE TO THE TIP AND TIP COILS. THE SHAPING RIBBON WAS SEPARATED AND TWISTED. DURING ANALYSIS THE TIP COILS GOT SEPARATED 1.1 CM DISTAL TO THE CENTER SOLDER. SEM ANALYSIS INDICATE THAT THE DEVICE CORE WAS SUBJECTED TO EXCESSIVE TORSIONAL OVERLOAD BEYOND ITS DESIGN LIMIT CAUSING THE SHAPING RIBBON TO DETACH. FOR THE GUIDEWIRE TO FAIL DUE TO TORSIONAL OVERLOAD, SOME PORTION OF THE WIRE WOULD HAVE TO BE TRAPPED EITHER IN THE ANATOMY OR IN ANOTHER DEVICE AND EXCESSIVE TORQUE APPLIED. THE CAUSE FOR THE TORQUE WAS NOT DESCRIBED, BUT THE SEM SHOWS THAT THE GUIDEWIRE HAD BEEN OVERTORQUED BEYOND THE STRENGTH OF THE GUIDEWIRE RESULTING IN GUIDEWIRE FAILURE. THOUGH A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE PROD EXPERIENCE THE ISSUE APPEAR TO BE RELATED TO CIRCUMSTANCES DURING THE PROCEDURE AND NOT A MFG RELATED QUAL ISSUE. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO NON-CONFORMITIES ASSOCIATED WITH THIS LOT NUMBER AND PART NUMBER. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION. THE REPORTED INCIDENT CIRCUMSTANCES WILL BE MONITORED. MFG INSPECTS 100% OF THE GUIDEWIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER, AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. MFG ASSURES THE QUAL OF THE GUIDEWIRE TIPS THROUGH VISUAL AND DIMENSIONAL INSPECTIONS AND 100% NON-DESTRUCTIVE PULL TEST OF THE TIP. ALSO SAMPLES ARE DESTRUCTIVELY TESTED TO FAILURE AND EACH LOT MUST PASS THE TEST REQUIREMENTS. QUAL INSPECTION VERIFIES THAT ALL REQUIREMENTS ARE MET. THIS MDR IS CONSIDERED CLOSED BY THE PROD PERF GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: A SEPARATED GUIDEWIRE HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: GUIDEWIRE SEPARATION. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE HAD COME "UNDONE", MEANING THAT THE TIP LOOKED LIKE IT HAD FRAYED DURING PLEADING. THERE WAS NO FORCE USED SUCH AS "JAILING" OR ANY OTHER KIND OF FORCE. THE GUIDEWIRE WAS RETRACTED AND WAS REPLACED WITH ANOTHER BALANCE GUIDEWIRE. THE PROCEDURE WAS FINISHED SUCCESSFULLY. NO ADD'L EVENT OR PT INFO IS AVAILABLE. THIS IS BEING REPORTED BASED ON THE RETURNED PROD EVAL WHICH REVEALED A SEPARATED SHAPING RIBBON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE WITH HYD DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8052685

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK