BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION PLUS 8FR. 50CC DILATOR/SHEATH

    MDR report key: 16903383 · Received May 10, 2023

    Report

    Report Number
    2248146-2023-00322
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 21, 2023
    Report Date
    June 22, 2023
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567107943
    PMA / PMN Number
    K112327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FULL NAME: (B)(6), MBA, RN, NURSE MANAGER ADDITIONAL REPORTER: DR. (B)(6). THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. COMPLAINT RECORD ID # (B)(4).

    Additional Manufacturer Narrative · 0

    THE INTRODUCER DILATOR AND SHEATH WERE RETURNED WITH THE DILATOR TUBING INSIDE THE SHEATH WITH DRIED BLOOD ON THE COMPONENTS. THE HUB OF THE DILATOR WAS FOUND BROKEN OFF FROM THE DILATOR TUBING. THE SHEATH AND THE RETURNED DILATOR WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE SHEATH WAS OBSERVED TO BE INTACT WITH NO DEFECTS. NO OTHER VISUAL DEFECTS WERE IDENTIFIED. THE EVALUATION CONFIRMS THE REPORTED PROBLEM WITH THE DILATOR. THE ROOT CAUSE OF THE ISSUE AT THIS TIME IS IMPOSSIBLE TO DEFINE. CAPA 830128 HAS BEEN INITIATED TO INVESTIGATE THIS ISSUE FURTHER AND IDENTIFY A ROOT CAUSE. REFERENCE COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY ON A STEMI PATIENT, THE SHEATH CRACKED BY THE TRANSITION POINT. THE DILATOR SNAPPED CAUSING THE MAIN DILATOR TO STAY IN THE SHEATH. DR. (B)(6) INDICATED COUNTERPULSATION THERAPY WAS INTENDED TO ASSIST WITH RESUSCITATION EFFORTS, CONFIRMING THE GETINGE IAB WAS INTENDED TO BE INSERTED IN A FEMORAL ARTERY WITH ARTERIAL ACCESS. THE DEVICE WAS REPORTED TO BE WITHOUT OBVIOUS DEFECT UPON REMOVAL FROM KIT, AND ASSEMBLY OF THE SHEATH DILATOR INTO THE GETINGE PROVIDED SHEATH WAS UNEVENTFUL. FEMORAL ACCESS WAS OBTAINED AND SHEATH/DILATOR ASSEMBLY WAS PASSED OVER THE WIRE WITHOUT EVENT. WHEN REMOVING THE DILATOR AND WIRE TOGETHER, DR. O¿COCHLAIN DISCOVERED THAT ONLY THE DILATOR HUB REMAINED ON THE WIRE, THE DISTAL PORTION OF THE DILATOR REMAINING WITHIN THE SHEATH. ATTEMPTS TO PASS A WIRE TO RETRIEVE THE DILATOR REMAINING WITHIN THE SHEATH WERE UNSUCCESSFUL. THERE WAS REPORTEDLY SOME PATIENT MOVEMENT DURING THE PROCEDURE BUT TIMING OR SEVERITY OF THE MOVEMENT COULD NOT BE CONFIRMED. DR. O¿COCHLAIN CONFIRMED VESSEL INJURY DID OCCUR, DESCRIBED AS ¿INTERNAL ILIAC DISSECTION¿, THE TIP OF THE DILATOR MAKING CONTACT WITH THE VESSEL WALL. DR. O¿COCHLAIN CONFIRMED THE INJURY WAS MANAGED MEDICALLY, AND THE FLOW DISTAL TO THE DISSECTION WAS NOT IMPACTED. THE DILATOR WAS SUBSEQUENTLY REMOVED WITH THE SHEATH (TOGETHER), BUT AS THE ARTERIAL ACCESS WAS LOST, AN ALTERNATIVE IAB WAS PLACED IN THE OPPOSING FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579222 SENSATION PLUS 8FR. 50CC DILATOR/SHEATH SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP 0684-00-0403-10 3000258553 10607567107943

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention UNKNOWN.