BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY

    MDR report key: 2122454 · Received June 13, 2011

    Report

    Report Number
    2029046-2011-00049
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). LOT # 15326284M EVALUATION: THE RETURNED CATHETER WAS TESTED AND PASSED ELECTRICAL TEST, TEMPERATURE BATH TEST, GENERATOR TEST, PATENCY AND FLOW RATE TEST AND FOR VISUAL CHARACTERISTICS INSPECTION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE COMPLAINT CONDITION COULD NOT BEEN CONFIRMED. LOT # 15326286M EVALUATION: THE RETURN DEVICE WAS TESTED AND PASSED ELECTRICAL TEST, TEMPERATURE BATH TEST, GENERATOR TEST, PATENCY AND FLOW RATE TEST. THE DEVICE WAS FOUND WITH CHAR ACCUMULATION WHEN RECEIVED RELATED TO BURNED BLOOD CELLS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED AS THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, 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

    THE CUSTOMER REPORTED TWO CATHETERS. FIRST CATHETER WAS REPORTED WITH TEMPERATURE ISSUES UPON INITIALIZING ABLATION WHERE THE CATHETER WOULD MEASURE OVER 50 C EVEN WHEN THEY INCREASE THE FLOW TO 30ML. SETTINGS: 30W 17-30ML FLOW. THE SAFETY MECHANISM OF THE STOCKERT 70 RF GENERATOR DID NOT ALLOW THE USER TO PROCEED FURTHER WITH THIS CATHETER TO AVOID PATIENT INJURY. THE SECOND CATHETER WAS REPORTED WITH HAVING NOISE ON POLES 1 AND 2 NOT ALLOWING TO PROCEED WITH THE CASE. THE CASE WAS COMPLETED WITH DIFFERENT CATHETERS AND THERE WAS NO PATIENT CONSEQUENCE REPORTED. ON (B)(6) 2011, THE ANALYSIS LAB DISCOVERED CHAR MATERIAL ON THE CATHETER THAT WAS NOT REPORTED BY THE CUSTOMER PREVIOUSLY. AS A RESULT, THIS COMPLAINT WAS RECLASSIFIED AS A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1266-01-S 15326286M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other