BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2618010 · Received June 15, 2012

    Report

    Report Number
    2029046-2012-00080
    Event Type
    Injury
    Date Received
    June 15, 2012
    Date of Event
    May 30, 2012
    Report Date
    May 31, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K892265
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 MODEL# M-4800-01, SERIAL # (B)(4), SMART TOUCH BIDIRECTIONAL, MODEL# D-1327-04-S, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THAT AN ISCHEMIC VT ABLATION PROCEDURE, THE PHYSICIAN ACCESSED THE LEFT VENTRICLE THROUGH THE DESCENDING AORTA AND STARTED MAPPING THE LEFT VENTRICLE. HE COULD NOT REACH CERTAIN AREAS HE DECIDED TO PERFORM A TRANSSEPTAL PUNCTURE. A SL0 SEATH FROM (B)(4) WAS USED FOR THE TRANSEPTAL PUNCTURE. IMMEDIATELY AFTER THE PUNCTURE THE PATIENT'S BLOOD PRESSURE STARTED DROPPING. THE TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED THE PERICARDIOCENTESIS. AFTERWARDS THE PATIENT WAS STABLE AND KEPT UNDER OBSERVATION. THE PHYSICIAN MENTIONED THAT THE CAUSE OF THE PERFORATION WAS UNKNOWN. THE PATIENT HAD A PREVIOUS HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEBSTER¿ ELECTROPHYSIOLOGY CATHETER ELECTRODE, PACEMAKER, TEMPORARY DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1085-197-S UNKNOWN_D-1085-197-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R