BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBSIDIO

    MDR report key: 19555651 · Received June 18, 2024

    Report

    Report Number
    2124215-2024-36272
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 9, 2024
    Manufacturer
    OBSIDIO, INC.
    Product Code
    KRD
    PMA / PMN Number
    K213385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: EVENT DATE NOT PROVIDED. USED FIRST DAY OF THE MONTH OF THE AWARE DATE.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: EVENT DATE NOT PROVIDED. USED FIRST DAY OF THE MONTH OF THE AWARE DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISCHEMIA REQUIRING ADDITIONAL INTERVENTION. OBSIDIO WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE GASTROINTESTINAL (GI) TRACT OF A PATIENT WITH GASTRIC BYPASS. UPON OPENING THE OBSIDIO, THE PACKAGING WAS NOTED TO BE DAMAGED. PATIENT HAD ISCHEMIA AND THE GI NEEDED TO BE RESECTED. THE PATIENT FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISCHEMIA REQUIRING ADDITIONAL INTERVENTION. OBSIDIO WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE GASTROINTESTINAL (GI) TRACT OF A PATIENT WITH GASTRIC BYPASS. UPON OPENING THE OBSIDIO, THE PACKAGING WAS NOTED TO BE DAMAGED. PATIENT HAD ISCHEMIA AND THE GI NEEDED TO BE RESECTED. THE PATIENT FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD CONTINUED BLEEDING AT THE ROUX LIMB FOR WHICH THE PATIENT ENDED UP GOING TO EMBOLIZATION GIVEN COMORBIDITIES AND THE NEED FOR ANTICOAGULATION/ANTIPLATELET THERAPY. EMBOLIZATION OF THE SUPPLY TO THE BLEED IN THE SMALL BRANCH OF THE SMA WAS PERFORMED USING 0.2-0.3ML OF OBSIDIO WITH THE STANDARD TECHNIQUE. THE CATHETER WAS PULLED FOLLOWING THE DELIVERY OF OBSIDIO. THE BLEEDING STOPPED AND THE PATIENT STABILIZED THAT DAY. THE PATIENT WAS SEEN ON ROUNDS THE FOLLOWING DAY WITH NO ISSUES NOTED. APPROXIMATELY 2-3 DAYS POST-PROCEDURE, THE PATIENT HAD ABDOMINAL PAIN AND LACTIC ACIDOSIS. A COMPUTERIZED TOMOGRAPHY (CT) SCAN DEMONSTRATED ISCHEMIA WITH NO PORTAL VENOUS GAS. THE PATIENT WAS TAKEN TO SURGERY AND HAD 15-20CM OF THE BOWEL RESECTED. THE PATIENT DID FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332478 OBSIDIO VASCULAR EMBOLIZATION DEVICE KRD OBSIDIO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention