BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿

    MDR report key: 3637204 · Received February 20, 2014

    Report

    Report Number
    9673241-2014-00061
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 28, 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 ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO [THERMOCOOL SF NAV] APPROVED UNDER [P030031/S034]. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT DURING THE MAPPING PHASE, THE PHYSICIAN DETECTED THAT THE CARDIAC SILUETTE DID NOT CONTRACT AS AT THE BEGINNING OF THE PROCEDURE. THE PROCEDURE CONTINUED AS NORMAL AND AFTER 10 MIN THE PHYSICIAN CHECKED WITH USING ECHOCARDIOGRAPHY BECAUSE THE PATIENT WAS HYPOTENSIVE AND HE DETECTED PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED THE PERICARDIOCENTESIS AND EXTRACTED THE LIQUID UNTIL THE PATIENT BUT THE PATIENT DIDN´T RECOVERED THE NORMAL BLOOD PRESSURE, THE PHYSICIAN DECIDED TO USE A PERICARDIAL DRAINAGE, THE PATIENT CONTINUED BLEEDING. THEN THE DOCTORS FROM DE ICU DEPARTMENT CAME AND TOOK CARE OF THE PATIENT. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. 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. THE CATHETER WAS ALSO EVALUATED FOR CARTO 3 AND SCREENING TEST. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. THE FORCE FEATURE WAS WORKING PROPERLY. 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.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH CARTO3, AFTER THE CS CATHETER WAS PLACED, THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH NO DIFFICULTIES, THE LASSO CATHETER WAS PLACED IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND THE NAVISTAR CATHETER WAS INTRODUCED THROUGH A SECOND TRANSSEPTAL SHEATH INTO THE LEFT ATRIUM. DURING THE MAPPING PHASE, THE PHYSICIAN DETECTED THAT THE CARDIAC SILHOUETTE DID NOT CONTRACT AS AT THE BEGINNING OF THE PROCEDURE. HE DECIDED TO USE ECHOCARDIOGRAPHY AND THERE WASN´T ANY SIGN OF LIQUID. THE PROCEDURE WAS CONTINUED AS NORMAL AND AFTER 10 MINUTES, THE PHYSICIAN CHECKED WITH USING ECHOCARDIOGRAPHY AGAIN BECAUSE THE PATIENT WAS HYPOTENSIVE AND HE DETECTED PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED THE PERICARDIOCENTESIS AND EXTRACTED THE LIQUID BUT THE PATIENT DIDN´T RECOVERED THE NORMAL BLOOD PRESSURE, THE PHYSICIAN DECIDES TO USE A PERICARDIAL DRAINAGE, THE PATIENT CONTINUED BLEEDING. THE PATIENT NEEDED BLOOD AND PLASMA TRANSFUSION AND AFTER THAT THE PATIENT WAS NOT STABLE. THEN THE PATIENT WAS MOVED TO THE ICU. THE PROCEDURE WAS STOPPED. DURING THE PROCEDURE, THERE WERE SOME ABLATION POINTS (WITH NO ERRORS IN THE STOCKERT EP SHUTTLE). THE PHYSICIAN STATED THAT THE PERFORATION MIGHT HAVE OCCURRED DURING THE MAPPING PHASE WITH THE NAVISTAR CATHETER THERMOCOOL SMARTTOUCH AND THE AGILIS SHEATH. DURING THE PROCEDURE THE FORCE VALUES WERE UNDER 40G EXCEPT IN A FEW SECONDS THAT SHOWED HIGH FORCE JUST BEFORE HIDING THE CATHETER INSIDE THE SHEATH. IN THAT MOMENT THE CATHETER WAS LOCATED IN THE MIDDLE OF THE LEFT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108331 THERMOCOOL® SMART TOUCH¿ LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S UNK_D-1336-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R