BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSON

    MDR report key: 5822916 · Received July 26, 2016

    Report

    Report Number
    3009498591-2016-00227
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    January 17, 2013
    Report Date
    July 29, 2016
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K071234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE PURPOSE OF IDENTIFYING CONCOMITANT DEVICES. THE REPORTED EVENT DESCRIBES SIDE EFFECTS FROM THE PROCEDURE OR PATIENT SYMPTOMS DUE TO THEIR CONDITION. THIS PRODUCT IS CONSIDERED A CONCOMITANT DEVICE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE THE END OF AN AFIB CASE, THE STEERING MECHANISM ON THE CATHETER (D7L202515RT, 15745519L-BEING RETURNED) DID NOT ALLOW FOR DEFLECTION TO OCCUR. THE CATHETER WAS REPLACED WITH (D7L202515RT, 15719378L-BEING RETURNED) AND THIS NEW CATHETER WAS NOT DEFLECTING PROPERLY. THE CATHETER WAS REPLACED WITH (D7L202515RT, LOT NUMBER UNKNOWN-DISPOSED OF) AND THE CASE RESUMED. CALLER IS REQUESTING TWO (2) REPLACEMENT CATHETERS. IT WAS ALSO REPORTED BY THE CALLER THAT THE FOLLOWING DAY THE PATIENT DEVELOPED A CARDIAC TAMPONADE. THE STATUS OF THE PATIENT AND THE TREATMENT ADMINISTERED TO THE PATIENT IS UNKNOWN. IN ADDITION TO THE THREE (3) CATHETERS REFERENCED ABOVE, THE FOLLOWING BWI DEVICES WERE IN USE: 6 F OCOTPOLAR DEFLECTABLE CATHETER (D608DR002RT, LOT NUMBER UNKNOWN-DISPOSED OF), 7 F EZ STEER CORONARY SINUS CATHETER (BD710DF282RTS, LOT NUMBER UNKNOWN-DISPOSED OF), TC NAVISTAR RMT CATHETER (NR7TCSIY, LOT NUMBER UNKNOWN-DISPOSED OF), TC SF FJ CURVE MANUAL CATHETER (BNI35FJH, LOT NUMBER UNKNOWN-DISPOSED OF), PREFACE SHEATH (301803M, LOT NUMBER UNKNOWN-DISPOSED OF), ACCUNAV 8F ULTRASOUND CATHETER (H243 1013596 25, LOT NUMBER UNKNOWN-DISPOSED OF), STOCKERT GENERATOR ((B)(4)), CARTO 3 RMT (R10073), CARTO 3 REFERENCE PATCH (CREFP6, LOT NUMBER UNKNOWN-DISPOSED OF), COOL FLOW PUMP (SERIAL NUMBER NOT PROVIDED), AND COOL FLOW TUBING (CFT001, LOT NUMBER UNKNOWN-DISPOSED OF).

    Description of Event or Problem · 1

    IT IS UNKNOWN IF THE PATIENT WAS PROVIDED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475010 ACUSON ULTRASOUND CATHETER OBJ SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV 8F-90

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R