BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3160480 · Received June 10, 2013

    Report

    Report Number
    9673241-2013-00184
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCT: CARTO 3, MODEL# M-4800-01, SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS WERE SATURATED WITH NOISE WHEN THE PIU IS TURNED ON AND WHEN THE PIU WAS TURNED OFF, THE NOISE WENT AWAY. THERE WERE NO ERRORS ON THE CARTO3 SYSTEM. THE NOISE OCCURRED ON THE DEFIBRILLATOR MONITOR, SIEMENS SENSIS MONITOR, AND PRUCKA, AS WELL AS CARTO SURFACE LEADS AT THE SAME TIME. THE NOISE REAPPEARED WHEN THE ABLATION CATHETER WAS PLUGGED IN. THE ABLATION CATHETER AND THE ABLATION ADAPTER CABLE WERE EXCHANGED AND NOISE ISSUE PERSISTED AND ERROR 8 APPEARS (NO PACING WAS BEING PERFORMED AT THE TIME, AND NO PACING CHANNELS WERE OPEN) APPEARED. THE NOISE ISSUE WAS RESOLVED BY CHANGING THE REDEL CABLE. FOR RESOLVING ERROR 8 WAS SUGGESTED TO REBOOT PIU BUT THE PHYSICIAN WAS CHOOSING TO ABLATE WITHOUT POINT ACQUISITION ON CARTO3 AND DID NOT REBOOT THE PIU. THEY WERE ABLE TO COMPLETE FAM MAP OF LEFT ATRIAL (LA). UPON TRYING TO TROUBLE SHOOT THE SURFACE LEAD NOISE, IC SIGNALS BECAME NOISY ON CARTO & PRUCKA. SO, THE IC NOISE OCCURRED AFTER MAP WAS COMPLETE, BUT SURFACE LEAD NOISE WAS PRESENT DURING FAM. 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 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 CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS WERE SATURATED WITH NOISE WHEN THE PIU IS TURNED ON AND WHEN THE PIU WAS TURNED OFF, THE NOISE WENT AWAY. THERE WERE NO ERRORS ON THE CARTO3 SYSTEM. THE NOISE OCCURRED ON THE DEFIBRILLATOR MONITOR, SIEMENS SENSIS MONITOR, AND PRUCKA, AS WELL AS CARTO SURFACE LEADS AT THE SAME TIME. THE NOISE REAPPEARED WHEN THE ABLATION CATHETER WAS PLUGGED IN. THE ABLATION CATHETER AND THE ABLATION ADAPTER CABLE WERE EXCHANGED AND NOISE ISSUE PERSISTED AND ERROR 8 APPEARS (NO PACING WAS BEING PERFORMED AT THE TIME, AND NO PACING CHANNELS WERE OPEN) APPEARED. THE NOISE ISSUE WAS RESOLVED BY CHANGING THE REDEL CABLE. FOR RESOLVING ERROR 8 WAS SUGGESTED TO REBOOT PIU BUT THE PHYSICIAN WAS CHOOSING TO ABLATE WITHOUT POINT ACQUISITION ON CARTO3 AND DID NOT REBOOT THE PIU. THEY WERE ABLE TO COMPLETE FAM MAP OF LEFT ATRIAL (LA). UPON TRYING TO TROUBLE SHOOT THE SURFACE LEAD NOISE, IC SIGNALS BECAME NOISY ON CARTO & PRUCKA. SO, THE IC NOISE OCCURRED AFTER MAP WAS COMPLETE, BUT SURFACE LEAD NOISE WAS PRESENT DURING FAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260802 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S 15745777L

    Patients

    Seq Age Sex Outcome Treatment
    1