BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_STERILMED

    MDR report key: 16093011 · Received January 4, 2023

    Report

    Report Number
    2134070-2023-00001
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 7, 2022
    Report Date
    January 3, 2023
    Manufacturer
    STERILMED, INC.
    Product Code
    NLH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT DETAILS (CATALOG/LOT#) WERE UNABLE TO BE OBTAINED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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 UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN UNKNOWN_STERILMED (QUAD CATHETER). THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. THERE WERE NO VISIBLE SIGNS ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WHEN CHECKING FOR A PERICARDIAL EFFUSION BEFORE GOING TRANSSEPTAL. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 140CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN THINKS THE RV CATHETER MAY HAVE BEEN ON THE FREE WALL AND PUNCTURED THROUGH THE FREE WALL OF THE RV. THE RV CATHETER WAS NOT A BWI PRODUCT BUT WAS A REPROCESSED QUAD CATHETER BY STERILMED. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS DUE TO THE PROCEDURE. PATIENT REMAINED STABLE AT END OF PROCEDURE. PATIENT STAYED OVERNIGHT. A TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED WHILE PREPARING FOR TRANSSEPTAL AND DOING PRELIMINARY STUDY. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE VISITAG MODULE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908050 UNKNOWN_STERILMED UNKNOWN NLH STERILMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R BWI- THMCL SMTCH SF BID, TC, D-F/D134805| UNKNOWN BRAND GENERATOR| UNKNOWN BRAND PUMP