BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 3243555 · Received July 23, 2013

    Report

    Report Number
    2029046-2013-00098
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OBJ
    PMA / PMN Number
    K070242
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US CATALOG #: FG540000, SERIAL #: (B)(4); STOCKERT 70 SYSTEM US CATALOG #: S7001, SERIAL #: (B)(4); COOL FLOW PUMP US CATALOG #: CFP002, SERIAL #: (B)(4); C3 CS REFSTAR ¿ DEFLECTABLE US CATALOG #: R7F282CT LOT #: 15784738M; WEBSTER 4 POLE US CATALOG #: F6QA252RT, LOT #: 15770478M; WEBSTER 4 POLE US CATALOG #: F6QA252RT, LOT #: 15345467M; EZ STEER THERMOCOOL SF NAV US CATALOG #: BNI35DFCT, LOT #: 15833764L. MANUFACTURER REFERENCE #¿S: (B)(4) ARE RELATED TO THE SAME EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE #: (B)(4). IT WAS REPORTED THAT WHILE DOING A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION IN THE LEFT VENTRICLE THE PATIENT'S OXYGEN SATURATION LEVELS DROPPED. FLASH PULMONARY EDEMA WAS SUSPECTED AT THAT TIME AND THE PATIENT WAS INTUBATED. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS IDENTIFIED BY INTRACARDIAC ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED AND FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. ACCORDING TO THE PHYSICIAN HE DIDN¿T CONSIDER THAT THIS EVENT WAS CAUSED BY ANY BWI PRODUCT MALFUNCTION. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THE CATHETER WAS EVALUATED FOR EEPROM, CARTO 3 AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE CATHETER WAS ALSO TESTED FOR TRANSDUCER FUNCTIONALITY. THE TESTING REVEALED THE TRANSDUCER ELEMENTS WERE IN GOOD CONDITIONS SINCE THEIR SENSITIVITY AND CAPACITANCE PASSED THIS TEST. FINALLY, A DEFLECTION TEST WAS PERFORMED AND CATHETER PASSED. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. 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 IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION IN THE LEFT VENTRICLE, THE PATIENT'S OXYGEN SATURATION LEVELS DROPPED. FLASH PULMONARY EDEMA WAS SUSPECTED AT THAT TIME AND THE PATIENT WAS INTUBATED. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS IDENTIFIED BY INTRACARDIAC ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED AND FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED TO INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT AND IT WAS STATED THAT THE PHYSICIAN WAS RETROGRADING INTO LEFT VENTRICLE WITH THE ABLATION CATHETER. ULTRASOUND CATHETER WAS IN THE RIGHT VENTRICLE. AFTER LARGE AND VIOLENT COUGHING (BELIEVED TO BE FROM PULMONARY EDEMA), THE PATIENT WAS INTUBATED. AFTER THIS EVENT A PERICARDIAL EFFUSION WAS OBSERVED. THE OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THE PROGNOSIS FOR THE PATIENT WAS GOOD AND THE PHYSICIANS¿ OPINION REGARDING THE CAUSALITY OF THE EVENT WAS POSSIBLE DEVICE AND PROCEDURE RELATED. ACCORDING TO THE PHYSICIAN HE DIDN¿T CONSIDER THAT THIS EVENT WAS CAUSED BY ANY BWI PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344180 SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER, INC (IRWINDALE) M-5723-05 OEM_M-5723-05

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R