BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF BI-DIRECTIONAL CATHETER

    MDR report key: 4141233 · Received October 3, 2014

    Report

    Report Number
    9673241-2014-00383
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. (B)(4). AS LOT # 16093954L WAS PROVIDED, 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. NON-BWI PRODUCTS USED: PRODUCT NAME: ST. JUDE ENSITE NAVX MAPPING SYSTEM, CATALOG #: UNKNOWN, SERIAL #: UNKNOWN; PRODUCT NAME: ST. JUDE CATHETER, CATALOG #: UNKNOWN, LOT #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED BOTH OF THE DEVICES FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SF BI-DIRECTIONAL CATHETER AND CHAR WAS NOTED UPON REMOVING THE CATHETER FROM PATIENT¿S BODY. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICES FOR EVALUATION. THE FIRST DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. NO CHAR WAS OBSERVED. THEREFORE THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. IN ADDITION, AN IRRIGATION TEST WAS PERFORMED AND CATHETER PASSED, NO OCCLUSION WAS OBSERVED. THE SECOND DEVICE WAS ALSO VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. NO CHAR WAS OBSERVED. THEREFORE THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. IN ADDITION, AN IRRIGATION TEST WAS PERFORMED AND CATHETER PASSED, NO OCCLUSION WAS OBSERVED. THE DEVICE HISTORY RECORD (DHR) FOR BOTH OF THE PRODUCTS 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 A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SF BI-DIRECTIONAL CATHETER AND CHAR WAS NOTED UPON REMOVING THE CATHETER FROM PATIENT¿S BODY. THERE WAS NO PATIENT CONSEQUENCE. THE PHYSICIAN CHOSE TO COMPLETE THE CASE BY CHANGING THE CATHETER TO A ST. JUDE MEDICAL CATHETER. SETTINGS DURING THE EVENT INCLUDE: TEMPERATURE AT 38 DEGREES AND IRRIGATION FLOW OF 2 ML/MIN TO 15 ML/MIN. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619724 THERMOCOOL® SF BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1314-02-S 16093954L

    Patients

    Seq Age Sex Outcome Treatment
    1