BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2231789 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03715
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 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 MFR: THE NC QUANTUM APEX MONORAIL (MR) DEVICE WAS RECEIVED FOR ANALYSIS WITH NO ORIGINAL PACKAGING. THERE WAS CONTRAST IN THE DISTAL LUMEN AND BALLOON. INSPECTION OF THE BALLOON IN A DEFLATED STATE REVEALED DAMAGE TO THE BALLOON. THE DAMAGE APPEARED AS A RIPPLING EFFECT ON THE BALLOON MATERIAL, WHICH EXTENDED THE LENGTH OF THE BALLOON. AN INFLATION DEVICE FILLED WITH WATER WAS USED TO INFLATE THE BALLOON TO RATED BURST PRESSURE (RBP) AND HELD PRESSURE FOR 20 MINUTES. THERE WAS NO EVIDENCE OF A PINHOLE OR DEFECT. THERE WAS A FEW SCRATCHES ON THE PROXIMAL END OF THE BALLOON. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL PRESENTED NO INDICATION OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 2.75 X 15MM NC QUANTUM APEX MR BALLOON WAS USED FOR PRE-DILATATION AND WAS INFLATED 1ST: 16ATMS AND 2ND: 20ATMS WHEN IT RUPTURED. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE 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 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 2.75 X 15MM NC QUANTUM APEX MR BALLOON WAS USED FOR PRE-DILATATION AND WAS INFLATED 1ST: 16ATMS AND 2ND: 20ATMS WHEN IT RUPTURED. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE 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 H7493912415270 13929041

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4): INFLATION DEVICE