BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC-EZ STEER TCOOL NONNAV THR

    MDR report key: 5060946 · Received September 8, 2015

    Report

    Report Number
    9673241-2015-00616
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    December 31, 2014
    Report Date
    August 21, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUE: 3 PATIENTS EXCESSIVE BRUISING IN ¿F-8¿ GROUP; 1 PATIENT EXCESSIVE GROIN BRUISING REQUIRE PROTAMINE IN ¿F-8¿ GROUP; 1 PATIENT EXCESSIVE GROIN BRUISING REQUIRE PROTAMINE IN ¿F-8¿ GROUP; 4 PATIENTS SMALL HEMATOMA IN ¿F-8¿ GROUP. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED] BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: LASSO CIRCULAR MAPPING CATHETER, CARTO MAPPING SYSTEM OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: 11.5-FR TRANSSEPTAL STEERABLE SHEATHS (AGILIS, ST. JUDE MEDICAL), INTRACARDIAC ECHOCARDIOGRAPHIC CATHETER (ACUSON, SIEMENS), NAVX MAPPING SYSTEM (ST. JUDE MEDICAL), FEMOSTOP COMPRESSION ASSIST DEVICE (ST JUDE MEDICAL). (B)(4). THE DEVICES WERE NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT EIGHT PATIENTS WITH SYMPTOMATIC, DRUG REFRACTORY ATRIAL FIBRILLATION IN CONTROL GROUP UNDER CATHETER ABLATION. THESE NINE PATIENTS SUFFERED LARGE HEMATOMAS WHICH REQUIRE INTERVENTION. THE AUTHOR ASSESSED THE EVENTS WERE NOT DEVICE RELATED BUT PROCEDURE RELATED. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THESE EVENTS ARE UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿VENOUS HEMOSTASIS POSTCATHETER ABLATION OF ATRIAL FIBRILLATION WHILE UNDER THERAPEUTIC LEVELS OF ORAL AND INTRAVENOUS ANTICOAGULATION.¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF THE ¿FIGURE-OF-EIGHT¿ (¿F-8¿) SUTURE TECHNIQUE FOR FEMORAL VENOUS HEMOSTASIS WHILE ON THERAPEUTIC DOSES OF INTRAVENOUS ANTICOAGULATION AT THE TIME OF SHEATH REMOVAL. THE STUDY CONDUCTED BETWEEN (B)(6) 2009 AND (B)(6) 2014. SUSPECTED DEVICE IS IRRIGATED-TIP ABLATION CATHETER THERMOCOOL , HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. OTHER SERIOUS AND NON-SERIOUS ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE (SERIOUS EVENTS ARE REPORTED TO FDA SEPARATELY): 2 PATIENTS TRANSIENT ISCHEMIC ATTACKS IN CONTROL GROUP; 3 PATIENTS ARTERIAL PSEUDOANEURYSMS IN CONTROL GROUP; 1 PATIENTS BLEEDING NEED BLOOD TRANSFUSION IN CONTROL GROUP; 12 PATIENTS EXCESSIVE BRUISINGS IN CONTROL GROUP; 7 PATIENTS SMALL HEMATOMAS IN CONTROL GROUP; 18 PATIENTS SLIGHTLY BLED WHICH REQUIRE FEMOSTOP IN CONTROL GROUP; 22 PATIENTS RECURRENT GROIN BLED WHICH REQUIRE FEMOSTOP IN CONTROL GROUP; 1 PATIENT ARTERIAL PSEUDOANEURYSM IN ¿F-8¿ GROUP; 2 PATIENTS LARGE HEMATOMA IN ¿F-8¿ GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594391 GENERIC-EZ STEER TCOOL NONNAV THR CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1295-00 UNKNOWN_EZ_STEER_TC_NNAV

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R