BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER

    MDR report key: 15882677 · Received November 29, 2022

    Report

    Report Number
    3023245-2022-00022
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 29, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008869
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 18-NOV-2022, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT 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 803. 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH SOUNDSTAR ECO 8FG. ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER WHEREIN THE STERILE CATHETER PACKAGING WAS REPORTED TO BE DAMAGED. IT WAS REPORTED THE PACKAGING OF THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER WAS DAMAGED. IT WAS NOTICED BEFORE BEING OPENED THAT THE PACKAGING WAS ALREADY PARTIALLY. OPENED. THE PHYSICIAN DIDN'T WANT TO USE THE PRODUCT FOR SAFETY REASONS SO A DIFFERENT SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER WAS OPENED FOR THE CASE. ADDITIONAL INFORMATION RECEIVED INDICATED THE DAMAGE WAS FOUND ON THE POUCH AND THE DEVICE WAS SECURED PROPERLY IN THE TRAY. THERE WAS NO DAMAGE TO THE DEVICE DUE TO ANY PART, JUST THE PACKAGING WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292446 SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10439236 G9270353 10846835008869

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SMARTABLATE GENERATOR KIT-US.| THMCL SMTCH SF BID, TC, D-F.