BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2991170 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01255
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 8, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR:EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE TIP WAS DAMAGED. MAGNIFIED INSPECTION REVEALED NO DAMAGE TO THE CATHETER. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE (RBP) WITH AN INFLATION DEVICE FILLED WITH WATER. THE DEVICE MAINTAINED RBP FOR FIVE (5) MINUTES WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. AFTER CONFIRMING THE DEVICE MAINTAINED RBP, THE DEVICE WAS DEFLATED BY APPLYING NEGATIVE PRESSURE WITH THE INFLATION DEVICE. FUNCTIONAL TESTING REVEALED NO EVIDENCE OF THE ALLEGED BALLOON BURST. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ADVANCED 20MM X 3.0MM NC QUANTUM APEX BALLOON CATHETER TO THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 11ATM. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ADVANCED 20MM X 3.0MM NC QUANTUM APEX BALLOON CATHETER TO THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 11ATM. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95786 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912420300 14930488

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR