BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 20865193 · Received December 6, 2024

    Report

    Report Number
    2134070-2024-00024
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 14, 2024
    Manufacturer
    STERILMED, INC.
    Product Code
    NLG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 ATRIAL FIBRILLATION ABLATION WITH A REPROCESSED PENTARAY NAV ECO CATHETER AND THE PATIENT EXPERIENCED ST ELEVATION, CARDIAC ARREST, AND CARDIAC FAILURE THAT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR) AND HOSPITALIZATION. AFTER INTUBATION, THE PATIENT HAD BLOOD COMING THROUGH THE ENDOTRACHEAL TUBE (ET TUBE). HEPARIN WAS REVERSED. MAPPING IN THE LEFT ATRIUM WITH A PENTARAY CATHETER WAS BEING PERFORMED AT THE TIME, HOWEVER, NO ABLATION HAD BEEN PERFORMED. THE PATIENT'S STATUS DETERIORATED WITHIN FIVE MINUTES OF THE DISCOVERY OF BLOOD IN THE ET TUBE. ST SEGMENT ELEVATION WAS NOTICED ON ECHOCARDIOGRAM AND A LOWERED EJECTION FRACTION APPEARED ON THE INTRACARDIAC ECHOCARDIOGRAM (ICE) IMAGE. WITHIN MINUTES OF THIS, THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY. CHEST COMPRESSIONS WERE STARTED. THE RHYTHM AND PULSE RETURNED, AND THE BLEEDING STOPPED FROM THE ET TUBE. THE PATIENT STABILIZED. THE PHYSICIAN CONTINUED TO LOOK FOR THE SOURCE OF THE BLEEDING. THERE WAS NO PERICARDIAL EFFUSION DETECTED ON ICE. THE PHYSICIAN STATED THEY DID NOT BELIEVE MAPPING WITH THE PENTARAY CATHETER CONTRIBUTED TO THE PATIENT EVENT. THE REPROCESSED DEVICES FUNCTIONED AS EXPECTED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE THE PATIENT RECEIVED CPR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488729 NA CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY, REPROCESSED NLG STERILMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R| L REPROCESS SDSTR ECO 8F-90 GE