BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7F ES STEER DS BI-DIRECTIONAL NAV CATHETER

    MDR report key: 3060375 · Received April 16, 2013

    Report

    Report Number
    9673241-2013-00106
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P990025/S12
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT WHILE ABLATING DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, THE PHYSICIAN HEARD A STEAM POP AND THE PATIENT WENT INTO THIRD DEGREE HEART BLOCK FOR 15 MINUTES. THE PATIENT THEN RETURNED TO NORMAL SINUS RHYTHM. THERE WAS NO MEDICAL INTERVENTION PERFORMED. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE EVENT WAS NOT LIFE THREATENING. THERE WAS NO IMPAIRMENT OF A BODY FUNCTION NOR DAMAGE TO A BODY STRUCTURE. THERE WAS NO EXTENDED HOSPITALIZATION STAY. THE OUTCOME IS THAT THE PATIENT RECOVERED. THE PROGNOSIS OF THE PATIENT IS EXCELLENT. THE UPDATED HEALTH STATUS IS THAT THE PATIENT IS WELL WITH NO ADVERSE COMPLICATION. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE REPORTED EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE, GENERATOR AND DEFLECTION TESTS. DURING THE ANALYSIS THE CATHETER FAILED THE CALIBRATION TEST DUE TO A PC BOARD FAILURE. 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 CATHETER FAILED THE CALIBRATION TEST DUE TO A PC BOARD ISSUE. HOWEVER, THE ROOT CAUSE OF THE STEAM POP AND THE HEART BLOCK REMAIN UNKNOWN. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE POTENTIAL PCB ISSUES/INTERMITTENCY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM, MODEL #: M-5463-01, SERIAL #: (B)(4). REGARDING THE BIOSENSE WEBSTER SYSTEMS, THE CUSTOMER WAS CONTACTED BY BWI FIELD SERVICE ENGINEER. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS ISSUE WAS NOT RELATED TO BWI SYSTEMS. THE CUSTOMER DECLINED SYSTEM SERVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ABLATING DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, THE PHYSICIAN HEARD A STEAM POP AND THE PATIENT WENT INTO THIRD DEGREE HEART BLOCK FOR 15 MINUTES. THE PATIENT THEN RETURNED TO NORMAL SINUS RHYTHM. THERE WAS NO MEDICAL INTERVENTION PERFORMED. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE EVENT WAS NOT LIFE THREATENING. THERE WAS NO IMPAIRMENT OF A BODY FUNCTION NOR DAMAGE TO A BODY STRUCTURE. THERE WAS NO EXTENDED HOSPITALIZATION STAY. THE OUTCOME IS THAT THE PATIENT RECOVERED. THE PROGNOSIS OF THE PATIENT IS EXCELLENT. THE UPDATED HEALTH STATUS IS THAT THE PATIENT IS WELL WITH NO ADVERSE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162872 7F ES STEER DS BI-DIRECTIONAL NAV CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1268-04-S 15712757M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other