BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX?

    MDR report key: 3220962 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04771
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE APEX CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP). THE BALLOON WAS DEFLATED, AS-RECEIVED. THERE WAS DRIED CONTRAST IN THE BALLOON AND INFLATION LUMEN. THE TIP WAS DAMAGED. THERE WAS NO EVIDENCE OF ANY PROXIMAL BOND ANOMALIES OR DISTAL OUTER NECKDOWN. THE MINIMUM OUTER DIAMETER (OD) OF THE PROXIMAL BALLOON BOND WAS MEASURED WITH A CALIBRATED SNAP GAUGE AND MEETS SPECIFICATION. THE CATHETER WAS SOAKED IN A WARM WATER BATH TO DISSOLVE SOLIDIFIED CONTRAST IN THE INFLATION LUMEN. A .014" GUIDEWIRE WAS INSERTED INTO THE TIP AND ADVANCED THROUGH THE LUMEN. AN INFLATION DEVICE FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON TO RATED BURST PRESSURE (RBP) FOR 5 MINUTES. THE DEVICE MAINTAINED RBP FOR WITH NO EVIDENCE OF LEAKS OR OTHER IRREGULARITIES. AFTER THE 5 MINUTE INFLATION PERIOD, NEGATIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE. THE DEVICE DEFLATED IN 6 SECONDS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A BALLOON DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED ARTERY. A 2.00MM X 15MM APEX¿ BALLOON CATHETER WAS USED FOR DILATION. THE DEVICE WAS INFLATED AT AN UNKNOWN RATE AND WAS DEFLATED. AS THE PHYSICIAN RE-INTRODUCED THE BALLOON TO ANOTHER LESION WITH AN UNSPECIFIED GUIDING CATHETER, IT WAS NOTED THAT THE DISTAL SHAFT WAS KINKED AND THE BALLOON COULD NOT BE DEFLATED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A BALLOON DEFLATION ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED ARTERY. A 2.00MM X 15MM APEX BALLOON CATHETER WAS USED FOR DILATION. THE DEVICE WAS INFLATED AT AN UNKNOWN RATE AND WAS DEFLATED. AS THE PHYSICIAN RE-INTRODUCED THE BALLOON TO ANOTHER LESION WITH AN UNSPECIFIED GUIDING CATHETER, IT WAS NOTED THAT THE DISTAL SHAFT WAS KINKED AND THE BALLOON COULD NOT BE DEFLATED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321308 APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895915200 16059067

    Patients

    Seq Age Sex Outcome Treatment
    1