BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3892885 · Received June 24, 2014

    Report

    Report Number
    9673241-2014-00233
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THE PRODUCT INVESTIGATION IS PENDING. (B)(4).

    Additional Manufacturer Narrative · 1

    LOT # REPORTED WAS 16047207M. (B)(4) IT WAS REPORTED THAT A PATIENT, 70 YEARS OLD, FEMALE, UNDERWENT AN AFIB ABLATION PROCEDURE WITH A SMARTTOUCH CATHETER AND SUFFERED A CARDIAC TAMPONADE. DURING THE MAPPING PHASE, THE PATIENT SUFFERED FROM A TAMPONADE. THE BLOOD PRESSURE DECREASED AND WITH AN ECHO, CONFIRMED THE ADVERSE EVENT. THE PHYSICIAN RAPIDLY REMOVED THE CATHETERS AND STARTED TO DRAIN THE BLOOD INSIDE THE PERICARDIUM. THE PATIENT RECOVERED AND AFTER 30 MINUTES THEY WENT ON WITH THE WHOLE PROCEDURE OF ATRIAL FIBRILLATION. IT WAS A MILD TAMPONADE THAT THEY COULD RESOLVE IN THE SAME LAB. THE PATIENT WAS FINE AND RECOVERING. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS POSSIBLE PROCEDURE-RELATED. THE EVENT REQUIRED A DAY HOSPITALIZATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND THAT THE PEEK HOUSING AND SHAFT TRANSITION CRACKED OPEN WITH BROWN MATERIAL INSIDE THE PEEK HOUSING. THE CLEAR SENSOR SLEEVE HAS REDDISH BROWN MATERIAL INSIDE OF IT, THIS CONDITION COULD HAVE OCCURRED DUE TO AN ABNORMAL FORCE DURING THE CATHETER MANIPULATION. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. A COOL FLOW PUMP TEST WAS PERFORMED AS WELL AND THE CATHETER PASSED SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE DEVICE HISTORY RECORD (DHR) 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. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT A AFIB ABLATION PROCEDURE WITH A SMARTTOUCH CATHETER AND SUFFERED A CARDIAC TAMPONADE. DURING MAPPING PHASE, THE PATIENT SUFFERED FROM A TAMPONADE. THE BLOOD PRESSURE DECREASE AND WITH AN ECHO CONFIRMED THE ADVERSE EVENT. THE PHYSICIAN RAPIDLY REMOVED THE CATHETERS AND STARTED TO DRAIN THE BLOOD INSIDE THE PERICARDIUM. THE PATIENT RECOVERED AND AFTER 30 MINUTES THEY WENT ON WITH THE WHOLE PROCEDURE OF ATRIAL FIBRILLATION. IT WAS A MILD TAMPONADE THEY COULD RESOLVE IN THE SAME LAB. THE PATIENT WAS FINE AND RECOVERING. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS POSSIBLE PROCEDURE-RELATED. THE EVENT REQUIRED A DAY HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368970 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-01-S UNK_D-1336-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R