BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1990025 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00367
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    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: AN EXAMINATION OF THE RETURN DEVICE REVEALED THAT BLOOD AND CONTRAST WERE VISIBLE THROUGHOUT THE DISTAL LUMEN. TIP DAMAGE WAS ALSO NOTED. THE BALLOON WAS PRESSURIZED WITH AN INFLATION DEVICE AND A PINHOLE WAS NOTED IN THE BALLOON MATERIAL 7MM FROM DISTAL TIP. INSPECTION OF THE REMAINDER OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN DEPLOYED A NON-BSC STENT AND ADVANCED THE 12MM X 3.75MM QUANTUM APEX BALLOON CATHETER TO POST-DILATE THE STENT. THE QUANTUM APEX BALLOON WAS INFLATED THREE TIMES, HOWEVER, DURING THE THIRD INFLATION THE BALLOON WAS INFLATED TO 16 ATMS AND RUPTURED. THE QUANTUM APEX BALLOON WAS REMOVED INTACT AND A 3.75MM X 15MM QUANTUM WAS USED TO COMPLETE THE PROCEDURE. 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 PROCEDURE A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN DEPLOYED A NON-BSC STENT AND ADVANCED THE 12MM X 3.75MM QUANTUM APEX BALLOON CATHETER TO POST-DILATE THE STENT. THE QUANTUM APEX BALLOON WAS INFLATED THREE TIMES, HOWEVER, DURING THE THIRD INFLATION THE BALLOON WAS INFLATED TO 16 ATMS AND RUPTURED. THE QUANTUM APEX BALLOON WAS REMOVED INTACT AND A 3.75MM X 15MM QUANTUM WAS USED TO COMPLETE THE PROCEDURE. 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 PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412370 13749617

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RINTATO| STENT: XIENCE| STENT: PROMUS| BALLOON CATHETER: NCQA