BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGATTA GUIDEWIRE

    MDR report key: 1181094 · Received September 29, 2008

    Report

    Report Number
    3006010712-2008-00012
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BRIVANT LTD.
    Product Code
    DQX
    PMA / PMN Number
    K060551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THE REGATTA WIRE WAS DAMAGED WHEN REMOVED FROM THE STERILE PACKAGE. PER THE ACCOUNT, "WHEN THE NURSE UNPACKED THE SGW, THE DOCTOR NOTICED THAT THE TIP WAS NOT STRAIGHT BUT KIND OF WAVY. HE DECIDED NOT TO USE IT." THE DEVICE WAS RETURNED TO BRIVANT, THE ORIGINAL MFR, FOR ANALYSIS AND INVESTIGATION. THE DEVICE WAS RETURNED FOR EVALUATION. VISUALLY, IT WAS FOUND TO BE NONCONFORMING. THE PRODUCT IS BENT AND WAVY AT THE DISTAL TIP. ALSO, THE COIL HAS BEEN MANIPULATED TO THE EXTENT THAT THE COIL HAS STRETCHED BY APPROXIMATELY 5MM DISTALLY TO THE COIL TO CORE JOINT. THIS STRETCH IN THE COIL IS THE CAUSE OF THE WAVY APPEARANCE OF THE WIRE. THE CAUSE OF THIS FAILURE IS LIKELY TO BE INDUCED BY HANDLING OF THE WIRE, INADVERTENTLY PUSHING THE COIL TOWARDS THE DISTAL TIP FROM THE COIL TO CORE JOINT. THIS MAY BE CAUSED BY WIPING THE COIL TOWARDS THE DISTAL TIP, AS IS COMMON PRACTICE IN CATHETER LABORATORIES OR DURING THE PROCESS OF REMOVING THE WIRE FROM THE DISPENSER. A 100% IN PROCESS INSPECTION IS CARRIED OUT PRIOR TO PLACING THE WIRE INTO THE DISPENSER, SO IT IS UNLIKELY THAT THE FAILURE OCCURRED DURING THE MANUFACTURING PROCESS. OTHER COMPLAINT FOR BENT WIRES HAVE BEEN INVESTIGATED AND FOUND THAT THE LIKELY CAUSE OF THE FAILURE WAS THE DISTAL TIP OF THE WIRE HAVING BEEN CAUGHT UP IN THE DISPENSER LUER. HOWEVER, IT IS UNLIKELY THAT THIS TYPE OF EVENT WOULD CAUSE STRETCH IN THE COIL AS EVIDENCED IN THE SAMPLE UNDER INVESTIGATION. IT IS CONCLUDED THAT THIS DAMAGE WAS MOST LIKELY CAUSED BY HANDLING THE COIL OF THE WIRE OR WIPING THE COIL OF THE WIRE PRIOR TO USE. THE BATCH RECORDS WERE REVIEWED AND FOUND TO BE ACCURATELY COMPLETED. THE ITEMS REVIEWED WERE TURNS TO FAILURE, TENSILE DATA AND ADEQUATE COMPLETION OF EACH PROCESS STEP. THERE WERE NO FAILURE NOTED FOR THIS BATCH. THE COMPLAINT OF WIRE DEFORMATION WAS CONFIRMED ON ANALYSIS AS WELL AS DISCOVERY OF COIL STRETCH THAT WAS NOT ADDRESS IN THE COMPLAINT. IT IS CONCLUDED THAT THIS DAMAGE WAS MOST LIKELY CAUSED BY HANDLING THE COIL OF THE WIRE OR WIPING THE COIL OF THE WIRE PRIOR TO USE. THE ROOT CAUSE OF THE STRETCHED COIL, THAT IS THE CAUSE FOR THE WAVY APPEARANCE, MAY BE ATTRIBUTED TO USER HANDLING OF THE DEVICE WHEN REMOVED FROM THE PACKAGE PRIOR TO USE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED, INDICATED THAT WHEN THE REGATTA GUIDEWIRE WAS REMOVED FROM ITS PACKAGE, THE PHYSICIAN NOTICED THAT THE TIP WAS NOT STRAIGHT BUT KIND OF WAVY. THE PROBLEM WAS IDENTIFIED APPROXIMATELY 1 CM FOR THE DISTAL END. THE PHYSICIAN DECIDED NOT THE USE THE DEVICE. THE PRODUCT WAS RETURNED FOR EVALUATION; HOWEVER, THE ANALYSIS IDENTIFIED THE WIRE WAS STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGATTA GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX BRIVANT LTD. NA 90006532

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK