BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY

    MDR report key: 1890326 · Received November 3, 2010

    Report

    Report Number
    9673241-2010-00077
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER COMPLAINED ABOUT LOW IMPEDANCE READINGS DURING RF ABLATION AND THE PATIENT DEVELOPED A QUERY PERFORATION DURING CASE. THE PATIENT WAS STABILIZED AND KEPT UNDER OBSERVATION FOR TWO EXTRA DAYS POST PROCEDURE PRIOR TO RELEASE. THE RETURNED CATHETER PASSED THE TEMPERATURE TEST, GENERATOR TEST, PATENCY FLOW TEST, COOL FLOW PUMP TEST AND DEFLECTION TESTS. HOWEVER, THE CATHETER FAILED ELECTRICAL AND LEAKAGE TESTS DUE TO LEAD WIRE NOT WELDED TO THE ELECTRODE #3. 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 RELEASE SPECIFICATION AND PROCEDURES. COMPLAINT CONDITION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHYSICIAN REPORTED TWO ISSUES DURING THIS EVENT, IMPEDANCE AND PERFORATION. THE IMPEDANCE ISSUE REPORTED DURING THIS EVENT IS NOT A REPORTABLE EVENT SINCE IT IS NOT A DEATH, NOT A SERIOUS INJURY AND IS NOT A REPORTABLE MALFUNCTION. THE CARDIAC PERFORATION REPORTED IN THIS EVENT WAS THE REPORTABLE CIRCUMSTANCE. HOWEVER, CARDIAC PERFORATION IS NOT CAUSED BY THE LOW IMPEDANCE ISSUES. "CARDIAC PERFORATION" IS A KNOWN RISK FOR EP PROCEDURES AND PRECAUTIONS ARE INCLUDED IN THE IFU FOR THIS PRODUCT. WE SEARCHED FOR PERFORATION EVENTS RELATED WHERE IMPEDANCE ISSUES WERE REPORTED AND ONLY ONE ADDITIONAL REPORT WAS FOUND (REPORT # 9673241-2010-00057 (B)(4)). HOWEVER, THE IMPEDANCE ISSUE REPORTED IN THIS EVENT WAS NOT CONFIRMED. (B)(4). PROBLEM DESCRIPTION: IT WAS REPORTED THAT THIS CATHETER REGISTERED LOW IMPEDANCE DURING RF ABLATION AND THE PATIENT DEVELOPED A QUERY PERFORATION DURING CASE. ROOT CAUSE: THE COMPLAINT CONDITION REPORTED ABOUT LOW IMPEDANCES WAS NOT CONFIRMED. OTHER FAILURE WAS DETECTED ON THIS CATHETER DURING THE ANALYSIS THAT IT IS NOT RELATED TO THE EVENT: NO SIGNAL WAS COMING OUT FROM THE ELECTRODE # 3 DUE TO A WIRE IMPROPERLY WELDED AND LOST CONTACT WITH THE RING ELECTRODE DURING HANDLING; THIS FAILURE FOUND IS NOT THE CAUSE OF THE REPORTED PERFORATION OR THE LOW IMPEDANCE FAILURE. CONTROLS ARE IN PLACE IN MANUFACTURING. A 100% ELECTRICAL TESTING IS PART OF THE MANUFACTURING PROCESS. THE AVERAGE COMPLAINT RATE FOR IMPEDANCE ISSUE IS (B)(4). BASED ON THE CURRENT COMPLAINT RATE, NO FURTHER ACTION HAS BEEN REQUIRED. THE COMPLAINT RATE IS MONITORED ON A MONTHLY BASIS. BIOSENSE WEBSTER INC. HAS PROCEDURES FOR ESCALATION PROCESS ONCE AN UPTREND IS OBSERVED DURING THE MONITOR OF COMPLAINTS. THE COMPLAINT RATE FOR PERFORATION EVENTS WHERE IMPEDANCE ISSUES WERE REPORTED IS NEGLIGIBLE SINCE THERE ARE ONLY TWO MDRS RELATED TO THIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER REGISTERED LOW IMPEDENCE READINGS IN THE RANGE OF 50 TO 80 OHMS DURING RF ABLATION.THE PATIENT DEVELOPED A QUERY PERFORATION DURING CASE, WAS STABILISED, AND KEPT IN HOSPITAL FOR TWO EXTRA DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-16-S 15155465

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R