BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3043101 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02105
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 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 TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: MAGNIFIED INSPECTION OF THE RETURNED DEVICE REVEALED NO DAMAGE TO THE CATHETER. THE DEVICE WAS INFLATED AND MAINTAINED RBP FOR FIVE (5) MINUTES WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. 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 IS NOT CONFIRMED AS THE RETURNED DEVICE DID NOT SHOW ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. USING A FEMORAL APPROACH, THE 99% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AFTER FAILING TO CROSS THE LESION WITH A 2.00 X 12MM NC QUANTUM APEX BALLOON CATHETER, THE PHYSICIAN ADVANCED A 2.00 X 8MM NC QUANTUM APEX BALLOON CATHETER TO THE LESION WHEN IT RUPTURED AT 14ATMS UPON FIRST INFLATION. THE RUPTURED BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. USING A FEMORAL APPROACH, THE 99% STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AFTER FAILING TO CROSS THE LESION WITH A 2.00 X 12MM NC QUANTUM APEX BALLOON CATHETER, THE PHYSICIAN ADVANCED A 2.00 X 8MM NC QUANTUM APEX BALLOON CATHETER TO THE LESION WHEN IT RUPTURED AT 14ATMS UPON FIRST INFLATION. THE RUPTURED BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146168 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408200 15324711

    Patients

    Seq Age Sex Outcome Treatment
    1