BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3180822 · Received June 20, 2013

    Report

    Report Number
    9673241-2013-00206
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN HAD THE IMPRESSION THAT THE TEMPERATURE AND IMPEDANCE READINGS WERE NOT ACCURATE. THE PHYSICIAN REMOVED THE CELSIUS THERMOCOOL CATHETER FROM THE PATIENT AND IT SHOWED CHAR/THROMBUS FORMATION. THEY CHANGED THE CABLE AND DOUBLE CHECKED THE CONNECTIONS. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY REPORTED. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT ON (B)(6) 2013. THE EVENT OCCURRED MOST LIKELY DURING AN IRRIGATED ABLATION. THE GENERATOR SETTING WAS 35° AND THE FLOW RATE WAS 30ML/MIN. THERE WAS AN IMPEDANCE RISE DURING THE EVENT. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL CATHETER IRRIGATION BEFORE OR AFTER THE EVENT. THE ABLATION WAS DELIVERED AT 45 SECONDS AT THE SAME SITE. THE GENERATOR WAS IN POWER CONTROL MODE. THE APPROXIMATE SIZE OF THE CHAR WAS 3-4MM². THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY CHANGING THE CATHETER. THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. THE TEMPERATURE MEASURED TOO HIGH. SWITCHING ON THE GENERATOR, THE TEMPERATURE ROOFED TO 48-50°. THE PHYSICIAN BECAME AWARE THAT THE TEMPERATURE WAS NOT CORRECT AS THE ISSUE HAPPENED TOO OFTEN. THERE WAS 1 ABLATION BEING DELIVERED AT THIS TEMPERATURE. THE TEMPERATURE CUT-OFF FUNCTIONED PROPERLY. THE CUT-OFF WAS SET TO 48°. THE IMPEDANCE WAS DISPLAYED GENERALLY TOO HIGH. THE PHYSICIAN NOTICED THIS IMPEDANCE ISSUE AS THE IMPEDANCE REMAINED EXCESSIVELY HIGHER THAN DURING THE BEGINNING OF THE PROCEDURE. THERE WAS ABLATION BEING DELIVERED AT THIS IMPEDANCE WHEN THE TEMPERATURE READING WAS STILL UNDER CONTROL. THE CHAR SIZE IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING (B)(4) 2013 AS THE ALERT DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280284 CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1189-03-S 15597038M

    Patients

    Seq Age Sex Outcome Treatment
    1