BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2810098 · Received October 31, 2012

    Report

    Report Number
    2134265-2012-06671
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS DETERMINED TO BE USER RELATED AS THE RATED BURST PRESSURE FOR THIS DEVICE WAS EXCEEDED. THE DFU STATES: "INFLATE THE BALLOON SLOWLY TO THE APPROPRIATE PRESSURE TO PERFORM PTCA OR POSTDILATATION OF A STENT. MAINTAIN NEGATIVE PRESSURE ON THE BALLOON BETWEEN INFLATIONS. DO NOT EXCEED THE RATED BALLOON BURST PRESSURE. REFER TO TABLE 2 OR TO THE BALLOON COMPLIANCE CHART. IF DIFFICULTY IS EXPERIENCED DURING BALLOON INFLATION, DO NOT CONTINUE INFLATION; DEFLATE AND REMOVE THE CATHETER." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS MIDDLE LEFT ANTERIOR DESCENDING ARTERY. ANOTHER MANUFACTURERS STENT WAS IMPLANTED AND THIS 8 MM X 3.75 MM NC QUANTUM APEX MR BALLOON CATHETER WAS USED FOR POST-DILATATION. THE BALLOON WAS INFLATED TO 24 ATM AND RUPTURED UPON THE 1ST INFLATION. THE DEVICE WAS REMOVED INTACT FROM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408370 14877796

    Patients

    Seq Age Sex Outcome Treatment
    1 RESOLUTE INTEGRITY STENT