BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1771713 · Received July 28, 2010

    Report

    Report Number
    2134265-2010-03197
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THE DEVICE WAS ATTACHED TO AN INFLATION UNIT AND A PINHOLE LEAK WAS NOTED AT THE DISTAL EDGE OF THE CENTER MARKERBAND. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND MARKERBAND COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE PINHOLE LEAK. NO OTHER DAMAGE WAS NOTED ALONG THE LENGTH OF THIS DEVICE. 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 INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ANGINA PECTORIS. ANGIOGRAPHY REVEALED THE 100% STENOSED CHRONIC TOTAL OCCLUSION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ECCENTRIC, DE NOVO LESION MEASURED 36MM IN LENGTH AND THE VESSEL DIAMETER WAS 4MM. RIGHT RADIAL ACCESS WAS OBTAINED AND PRE-DILATATION WAS PERFORMED. FIRST, A 1.25 X 15MM NON BSC BALLOON CATHETER WAS ADVANCED AND THE BALLOON WAS INFLATED TWICE TO 15 ATMS FOR 10 SECONDS EACH TIME. THE 15MM X 1.5MM MAVERICK 2 BALLOON CATHETER WAS THEN ADVANCED AND DURING INFLATION, THE BALLOON RUPTURED AT 11 ATMS. PRE-DILATATION WAS COMPLETED WITH ANOTHER OF THE SAME SIZE MAVERICK 2 BALLOON. RESIDUAL STENOSIS WAS 50% AND 2 NON BSC STENTS WERE IMPLANTED OVERLAPPING IN THE VESSEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ANGINA PECTORIS. ANGIOGRAPHY REVEALED THE 100% STENOSED CHRONIC TOTAL OCCLUSION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ECCENTRIC, DE NOVO LESION MEASURED 36MM IN LENGTH AND THE VESSEL DIAMETER WAS 4MM. RIGHT RADIAL ACCESS WAS OBTAINED AND PRE-DILATATION WAS PERFORMED. FIRST, A 1.25 X 15MM NON BSC BALLOON CATHETER WAS ADVANCED AND THE BALLOON WAS INFLATED TWICE TO 15 ATMS FOR 10 SECONDS EACH TIME. THE 15MM X 1.5MM MAVERICK 2 BALLOON CATHETER WAS THEN ADVANCED AND DURING INFLATION, THE BALLOON RUPTURED AT 11 ATMS. PRE-DILATATION WAS COMPLETED WITH ANOTHER OF THE SAME SIZE MAVERICK 2 BALLOON. RESIDUAL STENOSIS WAS 50% AND 2 NON BSC STENTS WERE IMPLANTED OVERLAPPING IN THE VESSEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815150 11851567

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR PILOT GUIDE WIRE 50 190 0.014¿¿| 1.25X15MM RYUJIN BALLOON CATHETER| EBU 3.5 LAUNCHER 6F GUIDE CATHETER| EXCEL STENTS: 4.0X28MM AND 4.0X24MM