BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 24570915 · Received March 11, 2026

    Report

    Report Number
    2134070-2026-00005
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    February 16, 2026
    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

    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 WERE FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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).

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, APPROXIMATELY 75 YEARS OLD, UNDERWENT A RIGHT SIDED ATRIAL TACHYCARDIA ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR CATHETER AND THE PATIENT EXPERIENCED ASYSTOLE, WHICH REQUESTED EXTERNAL PACING. IN ADDITION, THE PATIENT EXPERIENCED CHEST PAIN AND PERICARDIAL EFFUSION DUE TO CARDIAC PERFORATION TREATED WITH PERICARDIOCENTESIS WITH A NON-STERILMED QDOT CATHETER. THE PATIENT COMPLAINED OF CHEST PAIN DURING THE PROCEDURE AFTER ABOUT 15 MINUTES OR MORE INTO THE CASE. THE CHEST PAIN WAS BELIEVED TO BE FROM PACING AND THE PROCEDURE CONTINUED. A COUPLE OF MINUTES AFTER THE PATIENT COMPLAINED OF CHEST PAIN, A PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED USING THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) SOUNDSTAR CATHETER. THE PERICARDIAL EFFUSION WAS DUE TO CARDIAC PERFORATION. THERE WAS NO PERICARDIAL EFFUSION AT BASELINE. THE MEDICAL INTERVENTION PROVIDED WAS INTUBATION AND PERICARDIOCENTESIS IN WHICH 150ML OF FLUID WAS REMOVED. THE PATIENT ALREADY HAD A LEFT BUNDLE BLOCK FROM THE START OF THE PROCEDURE. THE DECANAV CATHETER AND QDOT CATHETER WERE PULLED BACK TO THE SHEATH AND THE ICE CATHETER REMAINED IN THE RIGHT VENTRICLE. THE PHYSICIAN MANEUVERED THE SOUNDSTAR CATHETER AND THE SOUNDSTAR CATHETER BUMPED INTO THE RIGHT BUNDLE OF HIS. THE PATIENT WENT ASYSTOLE. THE ASYSTOLE WAS CONFIRMED ON THE 12-LEAD SIGNAL DISPLAYED ON THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE STAFF USED A DEFIBRILLATOR TO EXTERNALLY PACE THE PATIENT AND THE PATIENT'S HEART RHYTHM EVENTUALLY RECOVERED. THE PROCEDURE WAS ABORTED. THE LAST KNOWN PATIENT STATUS WAS STABLE. THE PATIENT¿S OUTCOME OF THE ADVERSE EVENT WAS STABLE AND RECOVERED. THE PATIENT STAYED OVERNIGHT FOR OBSERVATION. THE PROCEDURAL ACT (ACTIVATED CLOTTING TIME) WAS ABOVE 300. APPROXIMATELY TWO CATHETER EXCHANGES OCCURRED DURING THE PROCEDURE. NO TRANSSEPTAL PUNCTURE SITE WAS PERFORMED AND NO ABLATION OCCURRED BECAUSE OF THE STAFF'S CONCERNS FOR THE PATIENT¿S WELLBEING. THE EVENT OCCURRED DURING MANEUVERING CATHETERS IN CHAMBER AND SETTING UP TO DO AN ELECTROPHYSIOLOGY STUDY. THE PATIENT DID NOT REQUIRE CARDIAC SURGERY. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR ONE HOUR, AND LOCAL ANESTHESIA FOR 30 MINUTES. THE PHYSICIAN¿S OPINION WAS THAT THE CANCELLATION OF THE PROCEDURE DID NOT CONTRIBUTE TO A DEATH OR A SERIOUS INJURY TO THE PATIENT. THE PHYSICIAN IS UNSURE ON THE CAUSE OF THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269516 NA REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. 2240352 10888551014441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R