BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO¿ XP ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3852389 · Received June 5, 2014

    Report

    Report Number
    2029046-2014-00158
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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.SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT NOISE CONTAMINATED ALL CATHETER SIGNALS. 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 DHR COULD NOT BE REVIEWED SINCE THERE WAS NO LOT NUMBER AVAILABLE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE SIGNAL NOISE OCCURRED 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 DID NOT HAVE ANY SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. THE CASE WAS COMPLETED BY CHANGING THE CATHETER WITHOUT ANY PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328903 HALO¿ XP ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1160-29-S UNKNOWN_D-1160-29-S

    Patients

    Seq Age Sex Outcome Treatment
    1