BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR ECO 8F ULTRASOUND CATHETER

    MDR report key: 15459687 · Received September 20, 2022

    Report

    Report Number
    3023245-2022-00009
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    August 24, 2022
    Report Date
    September 20, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008852
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. MANUFACTURER'S REFERENCE NUMBER: (B)(4). MANUFACTURER'S REPORT # 2029046-2022-02235. IMPORTER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY MANUFACTURER BIOSENSE WEBSTER INC (BWI) THAT AN UNKNOWN FEMALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND AN OPTRELL¿ MAPPING CATHETER WITH TRUEREF¿ TECHNOLOGY. THE OPTRELL AND SOUNDSTAR BECAME TANGLED AND THE PATIENT SUFFERED VASCULAR INJURY REQUIRING INTERVENTION. DURING A PVC CASE, THE PATIENT SUFFERED A VASCULAR INJURY. THE BWI COMPANY REPRESENTATIVE STATED THE OPTRELL CATHETER GOT ENTANGLED WITH THE ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER. THEY WERE MOVING THRU THE ATRIUM AND THE ICE CATHETER WENT THRU ONE OF THE OPTRELL SPLINES. THEY KEPT TRYING TO PULL THE OPTRELL CATHETER AND EVENTUALLY THEY PULLED THE SHEATH OUT THAT THE OPTRELL CATHETER WAS IN. THE PROXIMAL PADDLE THEN GOT ENTRAPPED WITH THE SHAFT OF THE ICE CATHETER. AS THEY CONTINUED TO PULL THE OPTRELL, BOTH THE ICE CATHETER AND THE SHEATH IT WAS IN, WENT OUT OF THE VEIN AND INTO THE TISSUE. THE PATIENT STARTED BLEEDING FROM THE LARGE HOLE. A VASCULAR SURGEON WAS CALLED AND HE TOLD THEM TO PULL IT ALL OUT OF THE SKIN. THEY PULLED THE OPTRELL, THE SHAFT OF THE ICE CATHETER AND THE SHEATH OUT OF THE SKIN AND THEN CUT THE OPTRELL CATHETER AND CUT THE ICE CATHETER AND THEY WERE ABLE TO REMOVE EVERYTHING. IT WAS ALSO NOTED THAT BEFORE THE CATHETER WAS PULLED, FLUOROSCOPY WAS NOT USED TO LOOK AT THE CATHETER. THE FELLOW TOLD THE PHYSICIAN TO LOOK ON FLUORO BEFORE THE CATHETER WAS PULLED BUT THEY DID NOT. THE MEDICAL INTERVENTION PROVIDED WAS A PURSE STITCH TO STOP THE BLEEDING OF THE VEIN AND PRESSURE WAS HELD FOR A LONG TIME. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126092 SOUNDSTAR ECO 8F ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10439011 E8396926 10846835008852

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| R