BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 6583596 · Received May 22, 2017

    Report

    Report Number
    2029046-2017-00176
    Event Type
    Injury
    Date Received
    May 22, 2017
    Date of Event
    April 26, 2017
    Report Date
    April 26, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OBJ
    PMA / PMN Number
    K140318
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED ON 5/31/2017. THEREFORE, EXPIRATION DATE AND MANUFACTURED DATE HAVE BEEN POPULATED. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 6/1/2017. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    STILL PENDING IS THE MANUFACTURED DATE AND EXPIRATION DATE. THEREFORE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO UPDATE THE. EXPIRATION DATE AND. MANUFACTURED DATE FIELDS. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM MODEL #: M-4800-01 SERIAL: (B)(4). EZ STEER CORONARY SINUS CATHETER MODEL #: D-1263-05-S LOT #: 17620119M NON BIOSENSE WEBSTER, INC. - ESOPHASTAR MAPPING CATHETER - (B)(4). NON BIOSENSE WEBSTER, INC. - HARTSPAN NEEDLE -(B)(4) NON BIOSENSE WEBSTER, INC. - MERIT MEDICAL SYSTEMS HEARTSPAN TRANSSEPTAL NEEDLE NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SL0 SHEATH (WITH DILATOR AND WIRE) BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A SOUNDSTAR ECO CATHETER AND PENTARAY NAVIGATIONAL ECO CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. PERICARDIOCENTESIS YIELDED 240 CC. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER THE ADVERSE EVENT AND AT THE TIME OF COMPLAINT UPDATE. THERE IS NO CONFIRMED INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT WAS IN SINUS RHYTHM AND ATRIAL FIBRILLATION DURING THE PROCEDURE. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. CARTO, COIL AND TRANSDUCER TEST WERE PERFORMED AND CATHETER PASSED ALL SPECIFICATION. NO ERROR FOUND. PRODUCT IS WORKING PROPERLY. 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. NO MALFUNCTION FOUND ON DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A SOUNDSTAR ECO CATHETER AND PENTARAY NAVIGATIONAL ECO CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. PERICARDIOCENTESIS YIELDED 240CC. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER THE ADVERSE EVENT AND AT THE TIME OF COMPLAINT UPDATE. THERE IS NO CONFIRMED INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT WAS IN SINUS RHYTHM AND ATRIAL FIBRILLATION DURING THE PROCEDURE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS NOT RELATED TO BIOSENSE WEBSTER, INC. PRODUCTS. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A HEARTSPAN TRANSSEPTAL NEEDLE. SHEATH IN USE WAS A ST. JUDE MEDICAL SL0 (WITH DILATOR AND WIRE). THERE IS NO INFORMATION REGARDING GENERATOR SETTINGS, IRRIGATED CATHETER FLOW SETTING, OR ANTICOAGULATION DURING THE PROCEDURE. THE ESOPHASTAR MAPPING CATHETER WAS NOT YET IN THE ESOPHAGUS. THE PENTARAY NAVIGATIONAL ECO CATHETER WAS IN USE AT THE TIME THE INJURY WAS NOTED. IT WAS NOTED THAT NO SMARTTOUCH ABLATION CATHETER WAS OPENED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362273 SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER, INC. (IRWINDALE) M-5723-17 OEM_M-5723-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R