BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTABLATE

    MDR report key: 6956045 · Received October 17, 2017

    Report

    Report Number
    2029046-2017-01027
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    September 20, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    4260166371093
    PMA / PMN Number
    P990071/S017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: THERMOCOOL SF NAV, US CATALOG #: D131504, LOT #: 17707932L. SMARTABLATE IRRIGATION TUBE SET US CATALOG #: SAT001, LOT #: ACG26058. LASSO CATHETER, US CATALOG #: UNKNOWN, LOT #: UNKNOWN. CARTO 3 SYSTEM, US CATALOG #: FG540000, SERIAL #: (B)(4). NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SR0 SHEATH. NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL LAMP 90 SHEATH. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A SMARTABLATE PUMP AND SUFFERED AN EMBOLISM REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, AFTER THE 2ND TRANSSEPTAL PUNCTURE, AIR WAS DETECTED IN THE AORTA. SHEATH AND ABLATION CATHETER WERE CONFIRMED TO BE IN THE AORTA VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PATIENT REMAINED STABLE. PATIENT WAS TRANSPORTED TO THE CARDIAC OPERATING ROOM WITH ALL SHEATHS AND CATHETERS IN PLACE TO PREVENT BLOOD LOSS. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR SURGICAL RECOVERY. PATIENT FULLY RECOVERED. REPAIR FOLLOW-UP WAS PERFORMED AND DEVICE WAS NOT SHIPPED FOR SERVICE. SERVICE WAS DECLINED. THE DEVICE HISTORY RECORD (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 A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A SMARTABLATE PUMP AND SUFFERED AN EMBOLISM REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, AFTER THE 2ND TRANSSEPTAL PUNCTURE, AIR WAS DETECTED IN THE AORTA. SHEATH AND ABLATION CATHETER WERE CONFIRMED TO BE IN THE AORTA VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PATIENT REMAINED STABLE. PATIENT WAS TRANSPORTED TO THE CARDIAC OPERATING ROOM WITH ALL SHEATHS AND CATHETERS IN PLACE TO PREVENT BLOOD LOSS. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR SURGICAL RECOVERY. PATIENT FULLY RECOVERED. IT WAS NOTED THAT THE PHYSICIAN DOES NOT BELIEVE THAT BWI PRODUCTS WERE RESPONSIBLE FOR THE INJURY. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PROCEDURE AND PATIENT CONDITION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN NON BIOSENSE WEBSTER, INC. UNSPECIFIED TRANSSEPTAL NEEDLE. SHEATHS INCLUDED A ST. JUDE MEDICAL SR0 SHEATH AND A ST. JUDE MEDICAL LAMP 90 SHEATH. NO ABLATION WAS PERFORMED. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME OF 354 SECONDS AT THE TIME OF THE ADVERSE EVENT. THE THERMOCOOL SF NAVIGATIONAL AND LASSO CATHETERS WERE IN USE AT THE TIME OF THE ADVERSE EVENT. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE UNDER THE SMARTABLATE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735845 SMARTABLATE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 4260166371093

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R