BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOA CATHETER CONVENIENCE KIT

    MDR report key: 20200895 · Received September 12, 2024

    Report

    Report Number
    3026788751-2024-00013
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 18, 2024
    Report Date
    August 19, 2024
    Manufacturer
    PRYTIME MEDICAL DEVICES, INC.
    Product Code
    OFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A INTRODUCER SHEATH WAS PLACED IN THE RIGHT FEMORAL ARTERY FOR USE WITH PREBOA-PRO CATHETER IN THE EMERGENCY DEPARTMENT IN A PATIENT WHO PRESENTED AS A LEVEL ONE TRAUMA ALERT. PATIENT HAD A SEIZURE AND WAS REPORTED TO HAVE BEEN INVOLVED WITH A MOTOR VEHICLE COLLISION THE DAY BEFORE BUT DID NOT SEEK MEDICAL ATTENTION. IN THE TRAUMA BAY, PATIENT WAS HYPOTENSIVE DESPITE RECEIVING BLOOD PRODUCTS. THE REBOA CATHETER WAS USED DUE TO THE HYPOTENSIVE STATE OF THE PATIENT, AND THE SURGEON WAS CONCERNED OF MISSING A RETROPERITONEAL BLEED AFTER A NEGATIVE FAST EXAM. AFTER A CT SCAN SHOWED NO OBVIOUS TRAUMATIC INJURIES, THE REBOA CATHETER WAS REMOVED WITHOUT ISSUE AND THE SHEATH REMAINED IN THE PATIENT. OF NOTE, HER BLOOD PRESSURE HAD BEEN LABILE THROUGHOUT THE HOSPITALIZATION, AND A SOURCE OF HER HYPOTENSION, MENTAL STATUS, AND POOR PERFUSION WAS BEING INVESTIGATED. THE RIGHT LEG WAS LATER FOUND TO BE COLD AND PULSELESS. APPROXIMATELY 2 HOURS AFTER THE REBOA WAS DEFLATED, A FOLLOW-UP CT ANGIOGRAM (CTA) OF THE LOWER EXTREMITY SHOWED A THROMBOSED/OCCLUDED EXTERNAL ILIAC ARTERY (FROM THE RIGHT COMMON ILIAC BIFURCATION AND LIKELY EXTENDING TO THE TIP OF THE ARTERIAL SHEATH) THOUGH THEY COULD NOT EXCLUDE THE POSSIBILITY OF A DISSECTION. THE SURGEON STATED THAT PLACEMENT OF THE SHEATH LIKELY CAUSED OR CONTRIBUTED TO THE FORMATION OF THE THROMBUS. ANOTHER POTENTIAL CAUSE FOR THE THROMBUS WAS THE POTENTIAL DISSECTION OF THE OPPOSITE SIDE OF THE INTIMA FROM THE SHEATH ENTRY POINT DUE TO THE PATIENT BEING SO HYPOTENSIVE AND HAVING COLLAPSIBLE VESSELS. A RIGHT PELVIC SIDEWALL HEMATOMA AND NEW SMALL HEMOPERITONEUM WAS ALSO FOUND ON THE FOLLOW-UP CTA. VASCULAR WAS CONSULTED AND TOOK PATIENT IMMEDIATELY TO THE OR FOR ENDOVASCULAR RECANALIZATION OF THE RIGHT EXTERNAL ILIAC ARTERY TO IMPROVE PERFUSION. IN THE OPERATING ROOM, THE PATIENT BECAME INCREASINGLY UNSTABLE AND ARRESTED. CPR, MEDICAL RESUSCITATION, AND DEFIBRILLATION WERE CARRIED OUT WITH NO RETURN OF SPONTANEOUS CIRCULATION AND THE PATIENT WAS PRONOUNCED DEAD. THE SURGEON STATED THAT THE SHEATH WAS NOT RESPONSIBLE FOR THE DEATH OF THE PATIENT, AND THE PATIENT WAS ACTIVELY DYING PRIOR TO GOING TO THE OR. THERE WAS NO CONFIRMED DEFICIENCY WITH THE PRYTIME PRODUCT EXHIBITED IN THIS CASE. THERE WAS NO REPORTED OR ALLEGED FAILURE OF THE KIT COMPONENTS INCLUDING THE INTRODUCER SHEATH, THE KIT, OR ITS LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505940 REBOA CATHETER CONVENIENCE KIT Catheter introducer kit OFC PRYTIME MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention