BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAGLIDE FOOT PEDAL

    MDR report key: 2925261 · Received January 22, 2013

    Report

    Report Number
    2134265-2013-00527
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATE: DEVICE AVAIL. FOR EVAL, RETURNED TO MFR. ON, DEVICE RETURNED TO MFR, DEVICE EVALUATED BY MFR. DEVICE EVALUATED BY MANUFACTURER: AN EXAMINATION OF THE RETURNED FOOT PEDAL FOUND IT FUNCTIONED PROPERLY, READILY ACTIVATING/DEACTIVATING THE BURR ROTATION AND SWITCHING THE CONSOLE BETWEEN TURBINE AND DYNAGLIDE MODES. AND DID NOT EXHIBIT ANY GAS/AIR LEAKS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS "NOT CONFIRMED". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE FOOT PEDAL FAIL TO RELEASE. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED VESSEL. THE PHYSICIAN WAS PERFORMING ABLATION USING A RC5000 CONSOLE ALONG WITH A DYNAGLIDE FOOT PEDAL WHEN IT WAS NOTED A HISSING SOUND WAS HEARD, BRASS CONNECTOR WERE LOOSE AND THE FOOT PEDAL WAS STICKING. WHEN THE PHYSICIAN PRESSED THE FOOT PEDAL TO START ABLATION SLOW RESPONSE WAS NOTED. WHEN THE FOOT PEDAL WAS PRESSED AGAIN TO STOP ABLATION AND/OR DYNAGLIDE WAS ACTIVATED FOR LONGER THAN INTENDED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE FOOT PEDAL FAIL TO RELEASE. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED VESSEL. THE PHYSICIAN WAS PERFORMING ABLATION USING A RC5000 CONSOLE ALONG WITH A DYNAGLIDE FOOT PEDAL WHEN IT WAS NOTED A HISSING SOUND WAS HEARD, BRASS CONNECTOR WERE LOOSE AND THE FOOT PEDAL WAS STICKING. WHEN THE PHYSICIAN PRESSED THE FOOT PEDAL TO START ABLATION SLOW RESPONSE WAS NOTED. WHEN THE FOOT PEDAL WAS PRESSED AGAIN TO STOP ABLATION AND/OR DYNAGLIDE WAS ACTIVATED FOR LONGER THAN INTENDED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29634 DYNAGLIDE FOOT PEDAL CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802224360021

    Patients

    Seq Age Sex Outcome Treatment
    1