BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2243454 · Received September 12, 2011

    Report

    Report Number
    2134265-2011-03772
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 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

    THE NC QUANTUM APEX MONORAIL (MR) DEVICE WAS RECEIVED WITH BLOOD AND CONTRAST IN THE DISTAL LUMEN AND BALLOON. A PINHOLE WAS LOCATED ON THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL PRESENTED NO INDICATION OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE PINHOLE. 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 IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY/PERIPHERAL INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS UNSPECIFIED VESSEL. THE 15MM X 2.00MM NC QUANTUM APEX BALLOON RUPTURED AT 18 ATMS. THE NUMBER OF INFLATIONS, AND TO WHAT ATMS, IS UNKNOWN. 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/PERIPHERAL INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS UNSPECIFIED VESSEL. THE 15MM X 2.00MM NC QUANTUM APEX BALLOON RUPTURED AT 18 ATMS. THE NUMBER OF INFLATIONS, AND TO WHAT ATMS, IS UNKNOWN. 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
    1 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415200 14012579

    Patients

    Seq Age Sex Outcome Treatment
    1