BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESEPT TRANSSEPTAL GUIDEWIRE

    MDR report key: 17519413 · Received August 12, 2023

    Report

    Report Number
    MW5126361
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    March 1, 2016
    Report Date
    March 9, 2016
    Manufacturer
    PRESSURE PRODUCTS, INC.
    Product Code
    DRC
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN AFIB. PROCEDURE A 52 Y.O. MALE PATIENT SUFFERED A CARDIAC PERFORATION DURING TRANSSEPTAL PHASE WHICH WAS NOTICED AFTER THE PHYSICIAN WAS NOT ABLE TO USE THE C3 MAPPING MODULE. NO ABLATION WAS PERFORMED. NO HEPARIN HAD BEEN GIVEN. NO MEDICAL INTERVENTION WAS PROVIDED. THE PATIENT STAYED OVERNIGHT FOR OBSERVATION. THE PATIENT WAS IN STABLE CONDITION. THE PHYSICIAN COMMENTED THAT THE ADVERSE EVENT WAS RESULTED FROM A VERY POSTERIOR TRANSEPTAL PUNCTURE AND BWI CATHETER WAS NOT AT FAULT. SMARTTOUCH (D133602 / 17377761M) ABLATION CATHETER WAS NOT ENTERED THE PATIENT BODY WHEN CARDIAC PERFORATION OCCURRED. THE ACCUNAV CATHETER WAS IN THE BODY. IT WAS A STERILMED RE?PROCESSED ACCUNAV WITH A CATALOG NUMBER OF R10135936. A TRANSSEPTAL PUNCTURE PERFORMED USING SAFESEPT WIRE (PRODUCT NUMBER SS-135) AND SL1 8.5 FR SHEATH. THIS COMPLAINT IS NOT MDR REPORTABLE UNDER BWI SMARTTOUCH ABLATION CATHETER AS ABLATION CATHETER WAS NOT ENTERED THE PATIENT BODY WHEN CARDIAC PERFORATION OCCURRED. SUSPECT DEVICE IS SAFESEPT WIRE WHICH WAS USED FOR TRANSSEPTAL PUNCTURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868815 SAFESEPT TRANSSEPTAL GUIDEWIRE TROCAR DRC PRESSURE PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown