BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 20753846 · Received November 21, 2024

    Report

    Report Number
    2134070-2024-00022
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 28, 2024
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    UDI-DI
    10888551014441
    PMA / PMN Number
    K110076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 STERILMED INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED 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. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A REPROCESSED SOUNDSTAR® ECO 10F DIAGNOSTIC ULTRASOUND CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED SURGICAL INTERVENTION. DURING THE AFIB CASE, AFTER THE PHYSICIAN WENT TRANSSEPTAL WITH THE SOUNDSTAR, THE BLOOD PRESSURE DROPPED SIGNIFICANTLY, THEN THE PHYSICIAN NOTICED THE EFFUSION. THE INJURY WAS CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAM AND BY PERFORMING A TRANSESOPHAGEAL ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS ATTEMPTED BUT WERE NOT ABLE TO DRAIN ANY FLUIDS. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS THEN TAKEN TO CARDIOTHORACIC SURGERY. THE LAST KNOWN STATUS OF THE PATIENT WAS STABLE. IT IS UNKNOWN WHAT LED TO THE INJURY. THE PLAN WAS TO DO PULSED FIELD ABLATION (PFA) WITH BOSTON SCIENTIFIC, BUT NO ABLATING WAS DONE BECAUSE AFTER TRANSSEPTAL, AN EFFUSION WAS NOTICED. THE SOUNDSTAR CATHETER FUNCTIONED AS EXPECTED, HOWEVER IT IS UNCLEAR IF THE SOUNDSTAR CATHETER WAS CONSIDERED TO BE A CONTRIBUTING FACTOR TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797558 NA REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. 2210550 10888551014441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R CARTO 3 SYSTEM| GENERATOR (BOSTON SCIENTIFIC)