BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 3961789 · Received July 28, 2014

    Report

    Report Number
    2015691-2014-01709
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LDF
    PMA / PMN Number
    K813521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BIPOLAR PACING CATHETER WITHOUT ANY ATTACHED COMPONENTS WAS RETURNED FOR EVALUATION. NO INTRODUCER OR SYRINGE WAS RETURNED. THE CATHETER TIP UNDER THE BALLOON WAS BENT APPROXIMATELY 22 DEGREES. THE CATHETER BODY WAS LOOPED AND TIED BY A SUTURE BETWEEN 34 AND 55 CM PROXIMAL FROM CATHETER TIP. AS RECEIVED, THE PROXIMAL LEADWIRE EXTENSION TUBE WAS DETACHED FROM THE Y-ADAPTOR UV BONDING SITE. UV BONDING APPEARED COMPLETELY CURED. THE PROXIMAL LEADWIRE WAS BROKEN OFF AT THE DETACHED SECTION AND THE CROSS SURFACE OF THE BROKEN PROXIMAL LEADWIRE APPEARED UNEVEN AND ROUGH. THERE WAS NO INDICATION OF STRETCHING TO THE EXTENSION TUBES OR CATHETER BODY TUBE. CONTINUITY TESTING WAS PERFORMED AND THERE WERE NO OPEN, INTERMITTENT, OR SHORT CONDITIONS OBSERVED AT THE DISTAL CIRCUIT, BETWEEN THE PROXIMAL ELECTRODE AND BROKEN SECTION, OR BETWEEN THE BROKEN SECTION AND THE PROXIMAL ELECTRODE CONNECTOR PIN. NO VISIBLE DAMAGE OR INCONSISTENCIES TO THE BALLOON OR BALLOON WINDINGS WAS OBSERVED. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3 CC AIR AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. BALLOON INFLATION TEST WAS PERFORMED USING LAB BD 5 CC SYRINGE WITH 1.3 CC AIR BY HOLDING THE BALLOON UNDER WATER. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION AND WITH THE UNAIDED EYES. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE COMPLAINT OF ¿PROXIMAL ELECTRODE GOT DETACHED FROM THE Y-ADAPTOR¿ WAS CONFIRMED DURING THE EVALUATION. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROXIMAL ELECTRODE GOT DETACHED FROM THE Y-ADAPTOR. IT BECAME UNABLE TO PACE. THE PATIENT WHO HAD COMPLETE HEART BLOCK (CHB) WENT INTO CARDIAC ARREST FOR ABOUT 25 SECONDS. ANOTHER CATHETER WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439704 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PACING CATHETER LDF EDWARDS LIFESCIENCES, PR PE074F5

    Patients

    Seq Age Sex Outcome Treatment
    1