BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS

    MDR report key: 8029864 · Received November 1, 2018

    Report

    Report Number
    1718850-2018-00019
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    September 27, 2018
    Report Date
    March 28, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    DWF
    UDI-DI
    00803622105913
    PMA / PMN Number
    K982891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, THE USER STATED THAT THE DEVICE TIP WAS PLACED THROUGH A PORT AND MUST HAVE FALLEN OFF WHEN IT WAS PULLED BACK THROUGH THE CHEST WALL. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE COMPLAINED CANNULA WAS NOT MADE AVAILABLE FOR INVESTIGATION. THE CUSTOMER PROVIDES A PICTURE SHOWING THE DETACHMENT OF THE TIP FROM THE BODY OF THE CANNULA. THE ISSUE IS CONFIRMED BASED ON THIS EVIDENCE. NO UNIT OF THE SAME LOT OF THE COMPLAINED CANNULA WAS AVAILABLE IN LIVANOVA USA WAREHOUSE. A PULL TEST, PERFORMED ON UNITS PULLED FROM THE STOCK, CONFIRMED THE BODING OF THE TIP WITH THE BODY OF THE CANNULA IS IN COMPLIANCE WITH PRODUCT SPECIFICATIONS. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. AS THE UNIT WAS NOT AVAILABLE FOR INVESTIGATION, NO SPECIFIC ROOT CAUSE OF THE ISSUE COULD BE IDENTIFIED. BASING ON FOLLOW UP INFORMATION WITH THE CUSTOMER, IT CANNOT BE EXCLUDED THAT THE DETACHMENT OF THE TIP WAS TRIGGERED BY INCORRECT HANDLING OF THE CANNULA DURING THE PROCEDURE. ACCORDING TO LIVANOVA COMPLAINT DATABASE, THIS IS NO OTHER SIMILAR EVENT OVER THE LAST YEAR. LIVANOVA USA WILL KEEP MONITORING THE MARKET. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    LIVANOVA RECEIVED A REPORT THAT THE TIP OF AN RIGID TIP SUCTION WAND USED DURING A MINIMALLY-INVASIVE VALVE REPAIR PROCEDURE ON (B)(6), 2018 WAS RETAINED IN THE PATIENT'S CHEST IN THE RIGHT PLEURAL CAVITY, CONFIRMED BY X-RAY, AFTER THE PROCEDURE. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON (B)(6) 2018 TO REMOVE THE DEVICE. THE TIP WAS REMOVED WITHOUT COMPLICATION VIA THE EXISTING INCISION. THE TIP WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870744 CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF LIVANOVA USA, INC. SU-XXXXX 1613800089 00803622105913

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R