BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1990339 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00196
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 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: AN EXAMINATION OF THE RETURNED DEVICE REVEALED BLOOD AND CONTRAST WERE VISIBLE THROUGHOUT THE DISTAL LUMEN. DAMAGE TO THE TIP WAS ALSO NOTED. MICROSCOPIC INSPECTION OF THE BALLOON WALL REVEALED A PINHOLE 10MM FROM DISTAL TIP. INSPECTION OF THE BALLOON MATERIAL AND RO MARKERS PRESENTED NO IRREGULARITIES THAT COULD HAVE CONTRIBUTED TO THE BALLOON RUPTURE. EXAMINATION OF THE REMAINDER OF THE DEVICE DID NOT REVEAL EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. 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 PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. A NON-BSC GUIDE WIRE AND A NON-BSC 7FR GUIDE CATHETER WERE ADVANCED. NEXT, THE PHYSICIAN ADVANCED THE 12MM X 2.25MM QUANTUM APEX BALLOON TO PREDILATE THE LESION AND INFLATED THE BALLOON ONCE TO 6 ATMS. THE BALLOON WAS THEN INFLATED ONCE TO 12 ATMS AND RUPTURED. 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 90% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. A NON-BSC GUIDE WIRE AND A NON-BSC 7FR GUIDE CATHETER WERE ADVANCED. NEXT, THE PHYSICIAN ADVANCED THE 12MM X 2.25MM QUANTUM APEX BALLOON TO PREDILATE THE LESION AND INFLATED THE BALLOON ONCE TO 6 ATMS. THE BALLOON WAS THEN INFLATED ONCE TO 12 ATMS AND RUPTURED. 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 H7493912412220 13785821

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: EVEREST| GUIDE CATHETER: HEARTRAIL 7F| GUIDE WIRE: GUIDEWIRE: RINATO