BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 6209883 · Received December 28, 2016

    Report

    Report Number
    2029046-2016-00268
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    P990025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. (B)(4). EVENT DESCRIPTION CONTINUATION: THE POWER WAS NOT TITRATED. THERE WERE NO ERROR MESSAGES ON BIOSENSE WEBSTER INC. EQUIPMENT DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS ORIGINATING IN THE RIGHT VENTRICULAR OUTFLOW TRACT WITH A NAVISTAR ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. IN ADDITION, THE PATIENT SUFFERED CARDIAC ARREST, WHICH REQUIRED COMPRESSIONS AND EPINEPHRINE. THE PATIENT IS A DIALYSIS PATIENT. DURING THE ABLATION PHASE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE EFFUSION WAS CONFIRMED BY TRANSTHORACIC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AS WELL AS A PERICARDIAL WINDOW. IT WAS ALSO REPORTED THAT THE PATIENT CODED TWICE, ONCE DURING THE PROCEDURE AND A SECOND TIME WHILE IN THE EMERGENCY ROOM. CHEST COMPRESSIONS AND EPINEPHRINE WERE ADMINISTERED TO THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AND WAS TRANSFERRED TO CEDARS SINAI MEDICAL CENTER BECAUSE THE OTHER HOSPITAL DID NOT HAVE THE ABILITY TO PERFORM EMERGENT CT SURGERY. THE EVENT WAS CONSIDERED LIFE THREATENING AND THE PATIENT¿S CONDITION HAS IMPROVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. PHYSICIAN INDICATED AFTER THE EVENTS THAT HE HEARD AN AUDIBLE STEAM POP AT 57 SECONDS AND THAT WAS THE REASON WHY HE SAID TO COME OFF ABLATION. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THE PATIENT DID NOT RECEIVE ANTICOAGULANT DURING THE PROCEDURE. THE FOLLOWING SHEATHS WERE USED DURING THE PROCEDURE: TERUMO 6FR X 2, 7FR X 1, 8 FR X 1. THE OVERALL ABLATION TIME AND LAST ABLATION CYCLE WAS 57 SECONDS. THE GENERATOR WAS IN TEMPERATURE CONTROL MODE. THE TEMPERATURE CUTOFF WAS 55°C, POWER CUTOFF WAS 50 WATTS. AT THE TIME OF INJURY, THE TEMPERATURE WAS 55°C, IMPEDANCE APPROXIMATELY 120 OHMS, POWER 50 WATTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861001 NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (IRWINDALE) D-1183-20-S UNKNOWN_D-1183-20-S

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R