BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA ICE PLUS¿

    MDR report key: 7341241 · Received March 15, 2018

    Report

    Report Number
    2134265-2018-01975
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 22, 2018
    Report Date
    February 22, 2018
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DXK
    UDI-DI
    08714729904373
    PMA / PMN Number
    K160173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN AND MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER BREAK / DETACHMENT OCCURRED. AN ULTRA ICE PLUS ULTRASOUND IMAGING CATHETER AND ANOTHER MANUFACTURER¿S SNARE WERE SELECTED FOR USE DURING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD EXTRACTION PROCEDURE IN THE RIGHT ATRIUM. DURING A TWISTING MANEUVER WITH THE SNARE RETRIEVAL DEVICE, THE CATHETER WAS ENTRAPPED WHILE IT WAS ROTATING AND THEREFORE BECAME DAMAGED. DURING RETRIEVAL OF THE DEVICES, THE PIEZOELECTRIC CRYSTAL BROKE AND DETACHED FROM THE CATHETER BODY. IT WAS NOTED THE DETACHMENT ¿PROBABLY¿ OCCURRED INSIDE THE SHEATH. ALL COMPONENTS WERE REMOVED FROM THE PATIENT WITHOUT PROBLEMS AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186436 ULTRA ICE PLUS¿ CATHETER, ULTRASOUND, INTRACARDIAC DXK BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00499100 20607150 08714729904373

    Patients

    Seq Age Sex Outcome Treatment
    1