BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 7041978 · Received November 17, 2017

    Report

    Report Number
    2029046-2017-01157
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 27, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    PMA / PMN Number
    K070242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCT: THERMOCOOL SMARTTOUCH BIDIRECTIONAL CATHETER, US CATALOG #: D132705. NON-BIOSENSE WEBSTER, INC. - ST. JUDE JSN QUADRIPOLAR CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A SOUNDSTAR CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS MONITORED FOR 30 MINUTES TO ASSESS FOR PVCS. ULTRASOUND REVEALED NO EFFUSION. HEPARIN WAS REVERSED, SHEATHS AND CATHETERS WERE REMOVED, AND ACTIVATED CLOTTING TIME (ACT) WAS CHECKED. PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM. ONE HOUR POST-PROCEDURE, WHILE IN THE RECOVERY ROOM, THE PATIENT BECAME HYPOTENSIVE AND REPORTED NAUSEA AND TINNITUS. ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. PATIENT WAS TRANSPORTED TO ANOTHER PROCEDURE ROOM FOR A PERICARDIOCENTESIS. PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), AND LATER WAS TRANSPORTED TO THE OPERATING ROOM FOR A SURGICAL INTERVENTION TO FIND THE SOURCE OF THE BLEEDING. INITIALLY, THE PHYSICIAN CONSIDERED THE POSSIBILITY OF AN AORTIC DISSECTION OR AN ABLATION-RELATED INJURY, BUT IT WAS DETERMINED THAT THE BLEEDING SOURCE WAS A RIGHT VENTRICULAR APEX PERFORATION. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR SURGICAL RECOVERY. PATIENT IS RECOVERING AND HAS IMPROVED. NO MAPPING OCCURRED IN THE RIGHT VENTRICLE. IT WAS NOTED THAT THE SOUNDSTAR CATHETER AND A ST. JUDE JSN QUADRIPOLAR CATHETER WERE USED FOR RIGHT VENTRICULAR PACING. ADVERSE EVENT WAS ASSESSED AS LIFE-THREATENING. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT HE MAY HAVE PERFORATED THE RIGHT VENTRICLE WITH THE SOUNDSTAR CATHETER. IT IS UNKNOWN WHEN THE INJURY OCCURRED. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE IS NO SHEATH INFORMATION. GENERATOR PARAMETERS, GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY WERE NOT REPORTED, AS THE INJURY WAS NOT ABLATION-RELATED. THERE IS NO INFORMATION REGARDING IRRIGATED CATHETER FLOW SETTING. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED AT GREATER THAN 350 SECONDS DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE, CATHETER PROXIMITY, OR CATHETER ZEROING. NO ERRORS WERE REPORTED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. IT WAS DETERMINED TO REPORT THIS EVENT UNDER THE SOUNDSTAR CATHETER AS IT WAS THE ONLY BIOSENSE WEBSTER, INC. CATHETER NOTED TO BE USED IN THE RIGHT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820598 SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R