BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 2011843 · Received March 9, 2011

    Report

    Report Number
    2134265-2011-00547
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 9, 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

    VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED SHAFT DAMAGE. THE SHAFT WAS STRETCHED FROM THE GUIDEWIRE EXIT NOTCH TO THE DISTAL END OF THE DEVICE. MICROSCOPIC INSPECTION REVEALED THE SHAFT WAS ACCORDIANED PROXIMALLY FROM THE DISTAL END OF THE DEVICE. THE DISTAL TIP WAS DETACHED/SEPARATED FROM THE DEVICE AND RETURNED STUCK TO THE PRODUCT MANDREL. THE DAMAGE TO THE DEVICE APPEARS TO BE CONSISTENT WITH THE BALLOON RECEIVING POSITIVE PRESSURE, CHANGING THE INNER DIAMETER OF THE LUMEN AND NOT ALLOWING THE PRODUCT MANDREL TO BE INSERTED FOR REWRAPPING. 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)

    Description of Event or Problem · 1

    COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT CROSS THE LESION AND THE SHAFT ELONGATED. THE 2.25X12MM MAVERICK 2 BALLOON WAS ADVANCED TO TREAT THE 99% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY, BUT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM OUTSIDE THE BODY FOR "REWRAPPING" AND THE MANDREL WAS CAREFULLY INSERTED INTO THE WIRE LUMEN. REWRAPPING WAS PERFORMED, HOWEVER THE PHYSICIAN WAS UNABLE TO REMOVE THE MANDREL FROM THE DEVICE AND THE SHAFT BECAME ELONGATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT THE CATHETER TIP SEPARATED AND STUCK TO THE MANDREL.

    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 H7493892812220

    Patients

    Seq Age Sex Outcome Treatment
    1