BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 1900008 · Received November 16, 2010

    Report

    Report Number
    2134265-2010-05156
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: THE DEVICE WAS RECEIVED IN TWO PIECES. BLOOD AND CONTRAST WERE PRESENT THROUGHOUT THE DISTAL SHAFT. THE DETACHED PROXIMAL PIECE MEASURED 49-1/4" FROM MANIFOLD. THE DETACHED DISTAL PIECE MEASURED APPROXIMATELY 10-1/2" AND WAS DAMAGED AND ACCORDIONED THROUGHOUT THE ENTIRE DISTAL SHAFT. MICROSCOPIC EXAMINATION OF THE DISTAL END OF THE DEVICE REVEALED DAMAGE TO THE DISTAL TIP. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE TIP DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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).

    Description of Event or Problem · 1

    EVENT IS REPORTABLE BASED ON INVESTIGATION COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A BALLOON CATHETER WOULD NOT CROSS A LESION. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE MAVERICK BALLOON CATHETER 15MM X 2.0MM WAS ADVANCED AND UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS STABLE. HOWEVER, PRODUCT ANALYSIS REVEALED A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493892815200 13235655

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR