BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELSIUS¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3171161 · Received June 14, 2013

    Report

    Report Number
    9673241-2013-00194
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    P950005/S2
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THAT THE PRODUCT ANALYSIS INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE, THE CATHETER WAS INSERTED INTO THE PATIENT'S BODY, THE POTENTIAL COULD NOT BE DISPLAYED ON SYSTEM WHEN THE CATHETER STRAIGHT. 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 AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE, THE CATHETER WAS INSERTED INTO THE PATIENT'S BODY, THE POTENTIAL COULD NOT BE DISPLAYED ON SYSTEM WHEN THE CATHETER STRAIGHT. FOLLOW UP WAS PERFORMED TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT AND IT WAS STATED THAT THE SIGNAL LOSS OCCUR ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE PROCEDURE WITH THE SIGNAL LOSS ISSUE. DUE TO THIS ADDITIONAL INFORMATION THIS EVENT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271279 CELSIUS¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1165-02-S 15758825M

    Patients

    Seq Age Sex Outcome Treatment
    1