BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THMCL SMARTTOUCH,TC,F,C3

    MDR report key: 7069443 · Received November 29, 2017

    Report

    Report Number
    2029046-2017-01166
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 7, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 12/04/2017. IT WAS REPORTED THAT ONE (B)(6)UNDERWENT RADIOFREQUENCY ABLATION USING SMARTTOUCH ABLATION CATHETER (CATALOG NUMBER D133602, LOT NUMBER 17179253M) AND DEVELOPED CARDIAC TAMPONADE WITH PERFORATION WHICH REQUIRED PERICARDIAL DRAINAGE AND EXTENDED HOSPITAL STAY. SHE WAS FULLY RECOVERED (NO RESIDUAL EFFECTS).THE AUTHOR COMMENTED THAT BWI DEVICE CITED IN THE ARTICLE THAT LED TO THE REPORTED PATIENT CONSEQUENCES, HOWEVER NO PRODUCT MALFUNCTION WAS REPORTED. THE CAUSALITY OF ADVERSE EVENT WERE POSSIBLE DEVICE RELATED AND POSSIBLE PROCEDURE RELATED. THE EVENT DID NOT RESULT IN THE IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17179253M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    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. MANUFACTURER'S REF. NO:(B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 1ST APVI WAS PERFORMED IN 75 CONSECUTIVE PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION USING CONTACT FORCE SENSING RADIOFREQUENCY CATHETER ABLATION. AMONG THEM, 1 PATIENT DEVELOPED PERICARDIAL TAMPONADE WITH PERFORATION TREATED WITH PERICARDIOCENTESIS IN CF-RFA GROUP 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, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿ABLATION OF PAROXYSMAL ATRIAL FIBRILLATION USING A 2ND GENERATION CRYOBALLOON CATHETER OR CONTACT-FORCE SENSING RADIOFREQUENCY ABLATION CATHETER: A COMPARISON OF COSTS AND LONG-TERM CLINICAL OUTCOMES¿. THE PURPOSE OF THIS STUDY WAS TO COMPARE THE COSTS AND LONG-TERM OUTCOMES OF APVI OF CBA USING THE 2ND-GENERATION CRYOBALLOON CATHETER AND A CONTACT FORCE-SENSING IRRIGATED-TIP ABLATION CATHETER (CF-RFA) IN PATIENTS WITH PAF. SUSPECT DEVICE IS A 3.5-MM OPEN IRRIGATED-TIP CONTACT FORCE SENSING SMARTTOUCH THERMOCOOL CATHETER, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845481 THMCL SMARTTOUCH,TC,F,C3 CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 17179253M

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R