BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3998963 · Received August 11, 2014

    Report

    Report Number
    9673241-2014-00300
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT AFTER CONNECTING THE CATHETER AT THE PIU, THE PIU SHUTDOWN. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND SOME GREENISH MATERIAL SIMILAR TO CORROSION WAS OBSERVED ON THE CONNECTOR. THEN PER THE REPORTED EVENT, THE CATHETER WAS EVALUATED FOR CARTO 3 AND IT WAS RECOGNIZED BY THE SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. PIU DID NOT RESTART. 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 A HYBRIDS PULMONARY VEIN ISOLATION (PVI), AFTER CONNECTING THE CATHETER AT THE PIU, THE PIU SHUTDOWN. FIRST THE CUSTOMER REPLACED THE CABLE, BUT THE SAME PROBLEM OCCURRED AGAIN. THE CASE WAS COMPLETED BY REPLACING THE CATHETER WITHOUT ANY PATIENT CONSEQUENCE. UPON FOLLOWING UP WITH THE CUSTOMER, BWI RECEIVED ADDITIONAL INFORMATION WHICH IS NOW INDICATIVE OF A REPORTABLE EVENT. IT WAS STATED THERE WAS 30 MINUTES DELAY BECAUSE OF THIS ISSUE AND THE PHYSICIAN THOUGHT THERE WAS ANY POTENTIAL RISK TO THE PATIENT DUE TO THIS DELAY SINCE THE PATIENT WAS UNDER GENERAL ANESTHESIA. A TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474742 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S UNKNOWN_D-1336-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1