BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER® CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 6070531 · Received November 1, 2016

    Report

    Report Number
    2029046-2016-00242
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 4, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K080425
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. CONCOMITANT PRODUCT: THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER (MODEL# D-1327-00-S, LOT# UNKNOWN). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A WEBSTER® CS CATHETER WITH AUTO ID TECHNOLOGY AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND AUTO-TRANSFUSION. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS OBSERVED. PERICARDIOCENTESIS YIELDED AN UNKNOWN AMOUNT OF BLOOD, WHICH WAS RETURNED TO THE PATIENT VIA AUTO-TRANSFUSION. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT WAS IN STABLE CONDITION IMMEDIATELY AFTER THE EVENT. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT FOR MONITORING. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. FACTORS THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THE PATIENT¿S ATYPICAL ANATOMY, SPECIFICALLY, A PERSISTENT LEFT SUPERIOR VENA CAVA. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PATIENT¿S ATYPICAL ANATOMY AND IT WAS CONFIRMED THAT THE INJURY WAS NOT RELATED TO ANY BWI CATHETERS. IT WAS NOTED THAT THE INJURY OCCURRED DURING TRANSSEPTAL PUNCTURE, WHEN THE PHYSICIAN INADVERTENTLY PUNCTURED THE CORONARY SINUS. THE INJURY WAS NOTICED DURING ABLATION PHASE WHILE USING FLUOROSCOPY AND CONFIRMED VIA ULTRASOUND. EVEN THOUGH THE PHYSICIAN¿S OPINION IS IT WAS NOT BWI PRODUCT RELATED, SINCE THE WEBSTER CORONARY SINUS CATHETER HAD BEEN IN THE CORONARY SINUS, WE ARE CONSERVATIVELY REPORTING THIS EVENT. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK NEEDLE. SHEATH USED WAS A ST. JUDE MEDICAL SL1. GENERATOR WAS SET ON POWER CONTROL MODE AT 30 WATTS. THERE IS NO INFORMATION REGARDING TITRATION. THERE WAS NO ABLATION AT THE SITE OF INJURY. IRRIGATED CATHETER FLOW WAS SET AT 8ML/MIN WHILE ABLATING AT 30 WATTS. THERE WERE NO ERROR MESSAGES REPORTED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIMES MAINTAINED BETWEEN 300-350 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720838 WEBSTER® CS CATHETER WITH AUTO ID TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (IRWINDALE) D-1353-03-S UNKNOWN_D-1353-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R