BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3221032 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04766
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE NC QUANTUM APEX CATHETER WAS RECEIVED INSIDE AN NC QUANTUM APEX SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL ON THE PROXIMAL END OF THE BALLOON. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED UNSPECIFIED CORONARY VESSEL. THE 8MM X 3.0MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE LESION AND INITIALLY INFLATED UP TO 12 ATMS. DURING THE SECOND INFLATION AT 12 ATMS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 15MM X 3.0MM NC QUANTUM APEX BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED UNSPECIFIED CORONARY VESSEL. THE 8MM X 3.0MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE LESION AND INITIALLY INFLATED UP TO 12 ATMS. DURING THE SECOND INFLATION AT 12 ATMS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 15MM X 3.0MM NC QUANTUM APEX BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320981 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408300 15297191

    Patients

    Seq Age Sex Outcome Treatment
    1