BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESEPT TRANSSEPTAL GUIDEWIRE

    MDR report key: 11912632 · Received June 1, 2021

    Report

    Report Number
    11912632
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 21, 2021
    Manufacturer
    PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
    Product Code
    DRC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    WIRE WELD POINT IS ABOUT 2CM FROM THE WIRE TIP AND IS CATCHING ON THE SEPTUM/HEART TISSUE WHEN PASSING THROUGH. THIS HAS GOTTEN WORSE OVER TIME. TWO FAILURES WERE SAVED, AND BOTH ARE AVAILABLE TO RETURN TO THE MANUFACTURER. PRODUCT HAD PATIENT CONTACT BUT NO PATIENT HARM. MANUFACTURER RESPONSE FOR SAFESEPT WIRE 135CM, (BRAND NOT PROVIDED) (PER SITE REPORTER) THE PRODUCT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    WIRE WELD POINT IS ABOUT 2CM FROM THE WIRE TIP AND IS CATCHING ON THE SEPTUM/HEART TISSUE WHEN PASSING THROUGH. THIS HAS GOTTEN WORSE OVER TIME. TWO FAILURES WERE SAVED, AND BOTH ARE AVAILABLE TO RETURN TO THE MANUFACTURER. PRODUCT HAD PATIENT CONTACT BUT NO PATIENT HARM. MANUFACTURER RESPONSE FOR SAFESEPT WIRE 135CM, (BRAND NOT PROVIDED) (PER SITE REPORTER). THE PRODUCT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808114 SAFESEPT TRANSSEPTAL GUIDEWIRE TROCAR DRC PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SS-135 000850

    Patients

    Seq Age Sex Outcome Treatment
    1