BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 1881540 · Received October 25, 2010

    Report

    Report Number
    9673241-2010-00075
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 30, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PHYSICIAN NOTICED A FOREIGN MATERIAL ON THE ELECTRODE AT THE END OF ABLATION. ACCORDING TO THE PHYSICIAN, THE IRRIGATION AND THE OPERATION OF THE ELECTRODE WERE NOT AFFECTED AND THE DEVICE WAS PERFORMING TO SPECIFICATION. IN ADDITION, THE CATHETER WAS REMOVED IN THE MIDDLE OF THE PROCEDURE BECAUSE THEY WANTED TO USE ANOTHER CATHETER; IT WAS THEN WHEN THEY FOUND THE FOREIGN MATERIAL. FURTHERMORE, THE FOREIGN MATERIAL WAS NOT PRESENT OR OBSERVED BY THE PHYSICIAN PRIOR TO THE USE OF THE CATHETER. ONCE THE CATHETER WAS RECEIVED AT BWI, A VISUAL INSPECTION WAS PERFORMED AND WAS FOUND A LIGHT STAIN ON TIP DOME THAT APPEARED TO BE BLOOD. THE FOREIGN BODY ON THE CATHETER WAS NOT RETURNED, AND THE CUSTOMER DID NOT KNOW IF THE FOREIGN BODY WAS CHAR OR PLASTIC. THE STAIN FOUND ON THE TIP COULD NOT BE FURTHER ANALYZED SINCE THE STAIN WAS ONLY A LIGHT MARK ON THE TIP. THE CATHETER WAS TESTED AND FLOW PATENCY, COOL FLOW PUMP AND ELECTRICAL TESTS WERE PERFORMED. THE CATHETER PASSED ALL THE TESTS AND PERFORMED AS DESIGNED. ALL CATHETERS ARE 100% INSPECTED BEFORE PACKAGING TO ASSURE PRODUCTS MEET ALL APPLICABLE SPECIFICATIONS AND QUALITY CRITERIA. THE DEVICE HISTORY RECORD 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. COMPLAINT CONDITION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, WHEN REMOVING THE CATHETER, THE PHYSICIAN NOTICED A FOREIGN BODY ON THE ELECTRODE. THE PHYSICIAN WAS UNSURE IF THE BODY WAS PLASTIC OR CHAR. THE FOREIGN BODY APPEARS TO BE CHAR FORMED AFTER ABLATION. THE CATHETER WAS REMOVED AS THE PHYSICIAN WANTED TO INSERT A LASSO CATHETER. THE IRRIGATION AND THE OPERATION OF THE ELECTRODE WERE NOT DISTURBED BEFORE FINDING THE FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1189-03-S 15094456

    Patients

    Seq Age Sex Outcome Treatment
    1