BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2944141 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00368
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 9, 2013
    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

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULTS CODES, CONCLUSION CODES: UPDATED. DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THERE WAS CONTRAST IN THE BALLOON 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 NEAR THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. 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 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 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS 2.25X12MM QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON WAS 1ST INFLATED AT 10 TO12ATMS, UPON THE 2ND INFLATION THE BALLOON RUPTURED AT AROUND 12ATM. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS 2.25X12MM QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON WAS 1ST INFLATED AT 10 TO 12ATMS, UPON THE 2ND INFLATION THE BALLOON RUPTURED AT AROUND 12ATM. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47573 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412220 15297881

    Patients

    Seq Age Sex Outcome Treatment
    1