BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE

    MDR report key: 3240554 · Received July 22, 2013

    Report

    Report Number
    2029046-2013-00092
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DYB
    PMA / PMN Number
    K982740
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US CATALOG #: FG540000, SERIAL #: (B)(4). LASSO NAV VARIABLE ECO US CATALOG #: D134301, LOT #: UNKNOWN. WEBSTER CS WITH AUTO ID US CATALOG #: D135304, LOT #: UNKNOWN. STOCKERT US CATALOG #: 39D-76X, SERIAL #: (B)(4). C3 EXTERNAL REFERENCE PATCH US CATALOG #: CREFP6, LOT #: UNKNOWN. C3 INTERFACE CABLE ¿ THERAPEUTIC US CATALOG #: CR3425CT, OEM LOT #: UNKNOWN. C3 ECO INTERFACE CABLE US CATALOG #: D134401, OEM LOT #: UNKNOWN. C3 INTERFACE CABLE ¿ DIAGNOSTIC US CATALOG #: CB3412CT OEM, LOT #: UNKNOWN. C3 INTERFACE CABLE ¿ DIAGNOSTIC US CATALOG #: CY1212CT, OEM LOT #: UNKNOWN. TRANSEPTAL NEEDLE US CATALOG #: FND01902, OEM LOT #: UNKNOWN - DISTRIBUTED WEBSTER 4 POLE W/ AUTO ID US CATALOG #: D6DR252CT, LOT #: UNKNOWN. EZ STEER THERMOCOOL NAV 4MM US CATALOG #: BNI75TCDFH, LOT #: UNKNOWN. BWI MANUFACTURER REFERENCE #¿S: (B)(4) ARE RELATED TO THE SAME EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PAROXYSMAL A-FIB PROCEDURE LISTED FOR LEFT ATRIAL CIRCUMFERENTIAL ABLATION (LACA), THE PHYSICIAN WAS OPERATING WITH ALL FOUR VEINS ISOLATED AND NO PROBLEMS OBSERVED. THE CATHETERS WERE REMOVED AND THE SHEATHS WITHDRAWN. IT WAS SHORTLY AFTER THE SHEATHS WERE WITHDRAWN THAT THE NON INVASIVE BLOOD PRESSURE WAS OBSERVED TO BE LOWER THAN PREVIOUS. THE BLOOD PRESSURE WAS REPEATED AND AGAIN PROVED TO BE LOW (APPROXIMATELY 70 MMHG SYSTOLIC). THE OPERATOR CALLED FOR AN ECHOCARDIOGRAM AND SCREENED THE PATIENT¿S CHEST TO CHECK FOR MOVEMENT OF THE HEAT BORDER WHICH MAY INDICATE AN EFFUSION. DURING THIS TIME THE PATIENT¿S BLOOD PRESSURE BECAME UNREADABLE BY THE NON INVASIVE CUFF AND A PERICARDIOCENTESIS KIT WAS OPENED. THE X-RAY WAS INCONCLUSIVE BUT WHEN THE ECHOCARDIOGRAM WAS PERFORMED A PERICARDIAL EFFUSION WAS OBSERVED. AN EMERGENCY PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY ONE LITER OF BLOOD WAS MANUALLY DRAINED FROM THE PATIENT¿S PERICARDIUM. THE PERICARDIAL DRAIN WAS LEFT IN SITE OVERNIGHT IN ORDER TO COLLECT A FURTHER BLOOD. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE EFFUSION WAS THAT THIS MAY OCCURRED WHEN THE PREFACE SHEATH WAS WITHDRAWAL. THE PHYSICIAN FELT THAT IT MAY HAVE PIERCED THE SEPTUM HIGH, CAUSING A SMALL HOLE INTO THE PERICARDIAL SPACE. IT WAS STATED BY THE PHYSICIAN THAT THIS EVENT COULD BE POSSIBLE DEVICE AND PROCEDURE RELATED. THE PATIENT REMAINED IN HOSPITAL OVERNIGHT BUT WAS REPORTED AS FULLY RECOVERED WITH NO FURTHER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340276 PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER, INC (IRWINDALE) 301803M OEM_301803M

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R