BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER? ELECTROPHYSIOLOGY CATHETER

    MDR report key: 4764166 · Received May 11, 2015

    Report

    Report Number
    2029046-2015-00134
    Event Type
    Injury
    Date Received
    May 11, 2015
    Date of Event
    June 1, 2011
    Report Date
    April 22, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: A NONCONTACT MAPPING SYSTEM ((B)(4)) (CARDIODRIVE, STEREOTAXIS) 4-MM-TIP ABLATION CATHETER (8FR HELIOS II, STEREOTAXIS) (B)(6).(B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE SOURCE. 4 PATIENTS IN MANUAL CATHETER CONTROL (MCC) GROUP DURING THE PROCEDURE, HAD MECHANICALLY INDUCED RIGHT BUNDLE BRANCH BLOCK (RBBB). TITLE: MAGNETIC VERSUS MANUAL CATHETER NAVIGATION FOR MAPPING AND ABLATION OF RIGHT VENTRICULAR OUTFLOW TRACT VENTRICULAR ARRHYTHMIAS: A RANDOMIZED CONTROLLED STUDY OBJECTIVES: THE PURPOSE OF THIS STUDY WAS TO PROSPECTIVELY EVALUATE THE EFFICACY AND SAFETY OF USING EITHER REMOTE MAGNETIC CONTROL (RMC) VS MCC FOR MAPPING AND ABLATION OF RVOT VPC/VT. BETWEEN JULY 2010 AND JUNE 2011, 30 CONSECUTIVE PATIENTS, MALE; MEAN AGE 44 WITH IDIOPATHIC VT OR VPC WERE RANDOMIZED IN 1:1 RATIO AND UNDERWENT ABLATION. IN SUBJECTS RANDOMIZED TO THE MCC GROUP, A 7FR QUADRIPOLAR CATHETER WITH 4-MM DISTAL ELECTRODE (CELSIUS, BIOSENSE WEBSTER, DIAMOND BAR, CA) WAS USED FOR MAPPING AND ABLATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE. IN SUBJECTS RANDOMIZED TO THE RMC GROUP, THE 4-MM-TIP ABLATION CATHETER (8FR HELIOS II, STEREOTAXIS) MNS (STEREOTAXIS INC, ST. LOUIS, MO) WAS USED IN PATIENTS. -1 PATIENT RMC GROUP DURING THE PROCEDURE, HAD MECHANICALLY INDUCED RIGHT BUNDLE BRANCH BLOCK (RBBB) -4 PATIENTS MCC GROUP DURING THE PROCEDURE, HAD MECHANICALLY INDUCED RIGHT BUNDLE BRANCH BLOCK (RBBB) OCCURRED ALL NORMALIZED DURING THE FIRST 6 MONTHS OF FOLLOW-UP. NO SEVERE COMPLICATIONS, SUCH AS CARDIAC PERFORATION, OCCURRED IN EITHER GROUP. THERE ARE NO DEATH EVENTS AND/OR DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. OTHER BWI PRODUCTS REPORTED IN THE ARTICLE: A NONCONTACT MAPPING SYSTEM ((B)(4)) (CARDIODRIVE, STEREOTAXIS); THE 4-MM-TIP ABLATION CATHETER (8FR HELIOS II, STEREOTAXIS) MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306514 WEBSTER? ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE 112547S, PMA # P950005 LPB BIOSENSE WEBSTER, INC (IRWINDALE) CELSIUS TC UNKNOWN_CELSIUS TC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening