BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MI,5F,40CMAT,7CMSMT

    MDR report key: 19268124 · Received May 8, 2024

    Report

    Report Number
    2134812-2024-00019
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    February 7, 2024
    Report Date
    April 9, 2024
    Manufacturer
    VASCULAR SOLUTIONS LLC
    Product Code
    DYB
    UDI-DI
    10841156102739
    PMA / PMN Number
    K180913
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). A PRODUCT EVALUATION COULD NOT BE COMPLETED AS THERE WAS NO PRODUCT RETURNED FOR EVALUATION. A DHR REVIEW WAS COMPLETED FOR LOT 73M2200054, AND NO ISSUES OR NONCONFORMITIES WERE NOTED. CASE DETAILS WERE REVIEWED. IT IS UNKNOWN WHERE EXACTLY THE SHEATH BROKE. THE IFU STATES THE FOLLOWING WARNING AND PRECAUTION: NEVER ADVANCE OR WITHDRAW AN INTRAVASCULAR DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. MOVEMENT OF THE GUIDEWIRE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE GUIDEWIRE TIP, DAMAGE TO THE GUIDEWIRE, OR VESSEL PERFORATION. AS PER THE REPORTED INFORMATION, PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE GUIDEWIRE. THIS INDICATES POTENTIAL ANATOMICAL ISSUES OR SOME CONCOMITANT DEVICE INTERACTION. NO DETAILS WERE PROVIDED BY THE CUSTOMER TO CONFIRM THE CASE. SURGERY WAS EMPLOYED BY CTVS SURGEON TO REMOVE THE SHEATH. A MANUFACTURING RECORD REVIEW WAS COMPLETED AND NO RELATED NONCONFORMANCES WERE FOUND. BASED ON THE LIMITED INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS UNDETERMINABLE. THE DER PROCESS WILL CONTINUE TO MONITOR FOR ANY SIMILAR EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THIS PATIENT WAS IN A MITRAL CLIP PROCEDURE. A PERICARDIAL EFFUSION WAS NOTED AFTER THE MITRAL CLIPS WERE RELEASED AND PERICARDIOCENTESIS WAS PERFORMED. DURING THE PERICARDIOCENTESIS, A MICRO INTRODUCER SHEATH WAS INSERTED, AND THE PHYSICIAN HAD A DIFFICULT TIME ADVANCING THE GUIDEWIRE. AFTER ATTEMPTING TO REWIRE THE MICRO SHEATH, THE MICRO INTRODUCER SHEATH BROKE, AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE SHEATH FROM THE PATIENT'S BODY. CVTS (CARDIOVASCULAR AND THORACIC SURGERY) WAS CONTACTED, AND THE OR (OPERATING ROOM) TEAM ARRIVED TO CATH LAB TO PERFORM A SMALL PERICARDIAL WINDOW TO RETRIEVE THE SHEATH. THE RETAINED PIECE OF SHEATH WAS RETRIEVED SUCCESSFULLY, AND FRAGMENTS WERE GIVEN TO CATH LAB MANAGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THIS PATIENT WAS IN A MITRAL CLIP PROCEDURE. A PERICARDIAL EFFUSION WAS NOTED AFTER THE MITRAL CLIPS WERE RELEASED AND PERICARDIOCENTESIS WAS PERFORMED. DURING THE PERICARDIOCENTESIS, A MICRO INTRODUCER SHEATH WAS INSERTED, AND THE PHYSICIAN HAD A DIFFICULT TIME ADVANCING THE GUIDEWIRE. AFTER ATTEMPTING TO REWIRE THE MICRO SHEATH, THE MICRO INTRODUCER SHEATH BROKE, AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE SHEATH FROM THE PATIENT'S BODY. CVTS (CARDIOVASCULAR AND THORACIC SURGERY) WAS CONTACTED, AND THE OR (OPERATING ROOM) TEAM ARRIVED TO CATH LAB TO PERFORM A SMALL PERICARDIAL WINDOW TO RETRIEVE THE SHEATH. THE RETAINED PIECE OF SHEATH WAS RETRIEVED SUCCESSFULLY, AND FRAGMENTS WERE GIVEN TO CATH LAB MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100824 MI,5F,40CMAT,7CMSMT INTRODUCER, CATHETER DYB VASCULAR SOLUTIONS LLC 73M2200054 10841156102739

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention NOT REPORTED.| NOT REPORTED.