BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2920751 · Received January 17, 2013

    Report

    Report Number
    2134265-2012-08552
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER:THE NC QUANTUM APEX CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP) WITHIN A NC QUANTUM APEX PRODUCT POUCH THAT MATCHED THE INFORMATION ON THE DEVICE. THERE WAS BLOOD AND CONTRAST IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL 2.5MM FROM THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (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 A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.25X16MM NC QUANTUM APEX BALLOON WAS ADVANCED FOR POST DILATION, HOWEVER, THE BALLOON RUPTURED ON THE 1ST INFLATION AT 14 ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.25X16MM NC QUANTUM APEX BALLOON WAS ADVANCED FOR POST DILATION, HOWEVER THE BALLOON RUPTURED ON THE 1ST INFLATION AT 14 ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25851 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415220 15353170

    Patients

    Seq Age Sex Outcome Treatment
    1