BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT

    MDR report key: 1025596 · Received April 2, 2008

    Report

    Report Number
    2024168-2008-00244
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 22, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE COILS. THERE WAS CORROSION ON THE TIPBALL, CENTER SOLDER AND PROXIMAL SOLDER. THE SHAPING RIBBON HAD SEPARATED 2.2 CM DISTAL TO THE CENTER SOLDER. THE SEPARATED PORTION WAS RETURNED AND WAS ATTACHED TO THE TIPBALL. THE SEPARATED PORTION WAS 9 MM IN LENGTH. THERE WAS NO PORTION OF THE SHAPING RIBBON MISSING. THE CORE WAS INTACT. THE TACKING BETWEEN THE CORE AND SHAPING RIBBON CAME APART DUE TO CORROSION. THE FRACTURED FACES OF THE SEPARATED SHAPING RIBBON WERE TWISTED FOR A LENGTH OF 0.5 MM PROXIMAL TO THE SEPARATION AND TWISTED 9 MM DISTAL TO THE SEPARATION. THE ENTIRE LENGTH OF THE TIP COILS WERE COMPLETELY STRETCHED OUT AND WERE A TOTAL OF 35 CM IN LENGTH. THE TIP COILS WERE INTACT AT THE TIPBALL AND HAD NOT SEPARATED. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THIS WAS SENT TO THE SCANNING ELECTRON MICROSCOPY LAB (SEM) FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE ANALYSIS OF THE RETURNED DEVICE. RESULTS OF THE SEM ANALYSIS INDICATES THAT THE DEVICE SHAPING RIBBON WAS SUBJECT TO EXCESSIVE DUCTILE AND TORSIONAL OVERLOAD BEYOND THE DESIGN LIMIT OF THE WIRE CAUSING THE TIP TO DETACH. FOR THE GUIDE WIRE TO FAIL DUE TO DUCTILE OVERLOAD, SOME PORTION OF THE GUIDE WE WOULD HAVE TO BE TRAPPED EITHER IN THE ANATOMY OR ANOTHER DEVICE AND EXCESSIVE PULL FORCE APPLIED. IN THIS CASE, IT APPEARS THAT THE GUIDE WIRE WAS TRAPPED IN THE ANATOMY. THE FORCES APPLIED IN THE ATTEMPT TO REMOVE THE GUIDE WIRE EXCEEDED THE STRENGTH OF THE SHAPING RIBBON WHICH FRACTURED. THE GUIDE WIRE CORROSION, AS FOUND IN THE ANALYSIS, IS RELATED TO DETERIORATION IN TRANSIT BACK TO ABBOTT AND IS NOT RELATED TO THE ISSUE. BECAUSE THE ISSUE APPEARS TO BE RELATED TO THE CIRCUMSTANCES EXPERIENCED DURING THE PROCEDURE AND NOT A QUALITY ISSUE IN EITHER MATERIALS OR WORKMANSHIP, NO CORRECTIVE ACTION CAN BE IMPLEMENTED. THIS IS A VERY LOW-LEVEL FAILURE MODE THAT IS MONITORED. MANUFACTURING ASSURES THE QUALITY OF THE GUIDE WIRE 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. QUALITY INSPECTION VERIFIES THAT ALL REQUIREMENTS ARE MET. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE SEPARATION HAS CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT ANOTHER CO'S STENT WAS IMPLANTED (DIRECT STENTING) AND POST-DILATATION WAS DONE WITH ANOTHER CO'S BALLOON CATHETER. THE TIP OF BALANCE HC GUIDE WIRE WAS STUCK IN THE DISTAL CX AND WAS UNABLE TO MOVE AT ALL WHEN THE ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE FROM THE PT'S BODY. THE SAME BALLOON CATHETER WAS FORWARDED TO THE DISTAL CX AND THE BALANCE HC GUIDE WIRE WAS REMOVED WITH THE BALLOON CATHETER'S SUPPORT. IT WAS STATED THAT THE BALANCE HC GUIDE WIRE TUGGED SHARPLY DURING THE REMOVAL ATTEMPT. THIS EVENT IS BEING FILED BASED ON THE RG LAB ANALYSIS OF THE DEVICE, WHICH REVEALED A GUIDE WIRE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7032071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE CATH: J&J XB3.5 7FR| STENT: CYPHER 3.5X13| DIL CATH: HIRYU 5.0X10MM| OTHER: IVUS