BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1943866 · Received January 3, 2011

    Report

    Report Number
    2134265-2010-05652
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    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 BALLOON CATHETER WAS RETURNED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. EXAMINATION IDENTIFIED DRIED BLOOD AND CONTRAST PRESENT THROUGHOUT THE DISTAL LUMEN. THE BALLOON CATHETER WAS RETURNED IN A DEFLATED STATE. THE BALLOON WAS INFLATED TO 6ATMS TO LOCATE THE BALLOON DEFECT AND A PINHOLE WAS IDENTIFIED IN THE BALLOON WALL, APPROXIMATELY 3.5MM FROM THE PROXIMAL BALLOON WAIST, PARALLEL WITH PROXIMAL MARKERBAND. EXAMINATION IDENTIFIED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE INNER LUMEN HAD A KINK 2MM FROM DISTAL END OF PROXIMAL MARKERBAND INSIDE THE BALLOON BODY. TIP DAMAGE WAS ALSO NOTED. 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 INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH A RADIAL ARTERY. THE 90% STENOSED, DE NOVO LESION WAS LOCATED IN A MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN IMPLANTED A PROMUS STENT AND POST DILATED WITH THE 3.0MM X 12MM NC QUANTUM APEX BALLOON. UPON THE SECOND INFLATION THE BALLOON WAS INFLATED TO 16ATMS AND RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT 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 CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH A RADIAL ARTERY. THE 90% STENOSED, DE NOVO LESION WAS LOCATED IN A MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN IMPLANTED A PROMUS STENT AND POST DILATED WITH THE 3.0MM X 12MM NC QUANTUM APEX BALLOON. UPON THE SECOND INFLATION THE BALLOON WAS INFLATED TO 16ATMS AND RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT 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
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412300 13840057

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO| GUIDE WIRE: TERUMO| GUIDE CATHETER: 6F MACH1 CLS3.5