BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2161382 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02581
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 13, 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: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH BLOOD AND CONTRAST PRESENT IN THE HUB AND LUMEN. THERE WAS A BALLOON PINHOLE 3.5MM FROM DISTAL EDGE OF PROXIMAL MARKER BAND. A SCRATCH WAS ALSO NOTED ON THE BALLOON NEXT TO THE PINHOLE. INSPECTION OF THE BALLOON MATERIAL PRESENTED NO INDICATION OF AN INITIATION POINT OR ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE PINHOLE. THE REMAINDER OF THE DEVICE PRESENTED 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 CONSIDERED OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (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 PROCEDURE, A BALLOON RUPTURE OCCURRED. THE VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN THE NON-CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THIS NC QUANTUM APEX MR 12MM X 3.00MM BALLOON CATHETER WAS USED FOR PREDILATION AND ADVANCED TO THE LESION WITHOUT RESISTANCE. ON THE FIRST INFLATION, THE BALLOON RUPTURED AT APPROXIMATELY 5 ATMS AFTER BEING INFLATED FOR 5 SECONDS. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. 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 CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN THE NON-CALCIFIED AND SEVERELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THIS NC QUANTUM APEX MR 12MM X 3.00MM BALLOON CATHETER WAS USED FOR PREDILATION AND ADVANCED TO THE LESION WITHOUT RESISTANCE. ON THE FIRST INFLATION, THE BALLOON RUPTURED AT APPROXIMATELY 5 ATMS AFTER BEING INFLATED FOR 5 SECONDS. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. 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
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412300 14054624

    Patients

    Seq Age Sex Outcome Treatment
    1