BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR ECO 8F ULTRASOUND CATHETER

    MDR report key: 15433541 · Received September 15, 2022

    Report

    Report Number
    2029046-2022-02235
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 24, 2022
    Report Date
    November 13, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008852
    PMA / PMN Number
    K140318
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC. OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 19-OCT-2022, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED 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. DEVICE EVALUATION DETAILS: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE TIP WAS CUT FROM THE DEVICE. OD TESTS WAS PERFORMED, AND THE DEVICE WAS WITHIN SPECIFICATIONS. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO RETURNED CONDITIONS. THE TIP OF THE DEVICE WAS CUT BY THE CUSTOMER AS THE EVENT DESCRIPTION STATES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR FINISHED DEVICE NUMBER E8396926, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED 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. MEDICAL DEVICE ENTRAPMENT WITH EXCESSIVE MANIPULATION REQUIRED IS MDR-REPORTABLE. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE. THIS REPORT IS FOR THE SOUNDSTAR ECO 8F ULTRASOUND CATHETER. THE REPORT FOR THE OPTRELL¿ MAPPING CATHETER WITH TRUEREF¿ TECHNOLOGY IS CONTAINED WITHIN MANUFACTURER REPORT NUMBER 2029046-2022-02234.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874947 SOUNDSTAR ECO 8F ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10439011 E8396926 10846835008852

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| L