BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1051686 · Received May 19, 2008

    Report

    Report Number
    2134265-2008-01442
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT THERE WAS A LARGE BUILD UP OF SOLIDIFIED BLOOD INSIDE THE BALLOON AND INFLATION LUMEN. THE BALLOON HAD BEEN INFLATED AND WAS NOT REFOLDED. THE PROFILE OF THE UNFOLDED BALLOON COULD POTENTIALLY HAVE CONTRIBUTED TO THE RESTRICTIONS EXPERIENCED BY THE PHYSICIAN IN ATTEMPTING TO CROSS THE LESION WITH THIS DEVICE. A CLOSER EXAMINATION OF THE BALLOON FOUND THAT A LONGITUDINAL TEAR EXISTED IN THE BALLOON MATERIAL. THE TEAR WAS LOCATED OVER THE DISTAL MARKERBAND AND EXTENDED PROXIMALLY ALONG THE BALLOON FOR A TOTAL LENGTH OF 7MM. A MICROSCOPIC EXAMINATION OF THE DISTAL MARKERBAND FOUND NO ISSUE. THE ACTUAL TEAR SITE WAS JAGGED IN APPEARANCE. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. TO DATE THERE ARE NO SIMILAR COMPLAINTS RELATED TO THIS MANUFACTURING BATCH NUMBER. THE ROOT CAUSE OF THIS DEFECT IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS APPROVED ON 04/30/2008. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE 2.5X15MM MAVERICK BALLOON WAS UNABLE TO CROSS THE LESION. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS, SEVERELY CALCIFIED AND 90% STENOTIC LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.5X15MM MAVERICK2 BALLOON TO THE LESION AND ENCOUNTERED SIGNIFICANT RESISTANCE AND WAS UNABLE TO CROSS THE LESION. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS NOT COMPLETED. PATIENT STATUS IS REPORTED AS "GOOD". HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE BALLOON WAS RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION MAVERICK2 15/2.5 0011329654

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR