BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD

    MDR report key: 1060746 · Received June 11, 2008

    Report

    Report Number
    2024168-2008-00475
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 12, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE GUIDE WIRE SEPARATION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITHOUT BLOOD AND CONTRAST VISIBLE. THERE WAS CORROSION PRESENT ON THE PROXIMAL SOLDER. THE CORE WAS DETACHED AT THE PROXIMAL END OF THE HYPOTUBE. THE FRACTURE FACES WERE OVALED AS IF KINKED PRIOR TO SEPARATION. THERE WERE SEVERAL OFFSET INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 1.3 CM. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE GUIDE WIRE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE. ANALYSIS OF THE RETURNED GUIDE WIRE CONFIRMED THE COMPLAINT AS THE GUIDE WIRE WAS RETURNED SEPARATED AT THE PROXIMAL END OF THE HYPOTUBE. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. SEM ANALYSIS OF THE SEPARATION SITE ATTRIBUTED THE SEPARATION TO DUCTILE OVERLOAD AT A BEND. THE GUIDE WIRE WAS THEREFORE SUBJECTED TO FORCES THAT EXCEEDED THE STRENGTH OF THE DEVICE. THE INCIDENT INFORMATION DID NOT DESCRIBE HOW THE GUIDE WIRE MAY HAVE BEEN BENT. GUIDE WIRES ARE FRAGILE AND IT IS POSSIBLE THAT DURING REMOVAL OF THE WIRE FROM THE DISPENSER HOOP, PREPARATION OF THE WIRE FOR USE OR LOADING OF THE GUIDE WIRE BACK INTO THE DISPENSER, THAT A BEND OF THIS TYPE COULD OCCUR THAT WOULD LATER FRACTURE. PUSHING AGAINST RESISTANCE COULD ALSO CAUSE THE GUIDE WIRE TO BEND. AS FOUND ON THE RETURNED DEVICE, THERE WERE ALSO SEVERAL OFFSET INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER. THIS TYPE OF DAMAGE IS TYPICALLY FOUND WHEN RESISTANCE IS ENCOUNTERED; HOWEVER, THERE ARE NO REPORTS OF RESISTANCE FELT. IN THIS CASE, THE ROOT CAUSE OF THE BEND AND SUBSEQUENT SEPARATION DUE TO DUCTILE OVERLOAD IS UNK; HOWEVER, THERE ARE NO INDICATIONS OF A MANUFACTURING RELATED QUALITY ISSUE WITH THE DEVICE. THE CORROSION FOUND IN THE ANALYSIS APPEARS TO BE FROM DETERIORATION IN TRANSIT BACK TO ABBOTT VASCULAR AND IS NOT RELATED TO THE REPORTED ISSUE. THE ROOT CAUSE COULD NOT BE DETERMINED; THEREFORE, NO ACTION CAN BE TAKEN IN THIS CASE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT THAT MIGHT HAVE CONTRIBUTED TO THE 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 PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE GUIDE WIRE WAS PREPARED AS USUAL FOR USE, AND AS IT WAS BEING INSERTED INTO THE GUIDING CATHETER, THE PHYSICIAN DECIDED NOT TO USE IT. THEN, AS THE GUIDE WIRE WAS BEING PUT BACK INTO THE COIL, THE GUIDE WIRE FRACTURED. IT NEVER ENTERED INTO THE PT'S ANATOMY. REPORTEDLY, THERE WAS NO PT INVOLVEMENT WITH THIS DEVICE. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7112783

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR