BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREBOA-PRO CATHETER

    MDR report key: 17674978 · Received September 2, 2023

    Report

    Report Number
    3026788751-2023-00014
    Event Type
    Injury
    Date Received
    September 2, 2023
    Date of Event
    August 2, 2023
    Report Date
    September 2, 2023
    Manufacturer
    PRYTIME MEDICAL DEVICES, INC.
    Product Code
    MJN
    PMA / PMN Number
    K200459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO FACTORS MAY HAVE PLAYED A ROLE IN THE TECHNICAL DIFFICULTIES SUMMARIZED ABOVE. ONE, IT IS UNKNOWN WHETHER ALL FLUID WAS COMPLETELY REMOVED FROM THE BALLOON PRIOR TO ATTEMPTED REMOVAL. AS NOTED IN THE IFU, FAILURE TO REMOVE ALL FLUID FROM THE BALLOON PRIOR TO ATTEMPTED REMOVAL MAY MAKE IT DIFFICULT OR IMPOSSIBLE TO REMOVE THE CATHETER FROM THE INTRODUCER SHEATH AND/OR VESSEL. THE SECOND IS THE PROCESS STEPS IN WHICH THE CATHETER AND SHEATH WERE REMOVED. AGAIN, PER THE IFU, "IF DIFFICULTY IS ENCOUNTERED WHEN REMOVING THE CATHETER, REMOVE THE CATHETER AND INTRODUCER SHEATH AS A UNIT." DURING THIS CASE, THE SHEATH WAS REMOVED FIRST, THEN THE CATHETER BALLOON WAS REMOVED; THESE INDIVIDUAL STEPS MAY HAVE CAUSED A LARGER OPENING AT THE ACCESS SITE, THUS REQUIRING SURGICAL INTERVENTION FOR CLOSURE.

    Description of Event or Problem · 0

    PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION AS THE REBOA CATHETER WAS PRESENT DURING A CASE THAT REQUIRED SURGICAL REPAIR OF THE RIGHT FEMORAL ARTERY AFTER REMOVAL. THE CASE INVOLVED A MALE PATIENT WHO WAS PRESENTED TO THE ED WITH HEMATURIA. THE PATIENT HAD A LONG-STANDING DRAIN IN PLACE AND WAS ON LONG-TERM ANTIBIOTICS FOR AN INFECTED LEFT KIDNEY. THE PATIENT WAS TRANSFERRED TO THE CT SCANNER WHICH REVEALED A LARGE PERINEPHRIC MASS, WHICH THE SURGEON THOUGHT WAS AN ABSCESS OR HEMATOMA. DURING THE CT, THE DRAIN WAS PULLED, AND THE PATIENT'S BLOOD PRESSURE DROPPED. A REPEAT CT SCAN REVEALED FREE INTRABDOMINAL FLUID, WHICH WAS SUSPECTED TO BE BLOOD. THE PATIENT'S RETROPERITONEUM HAD RUPTURED INTO THE INTRAPERITONEAL. THE PATIENT WAS INTUBATED, AND HIS BLOOD DROPPED SIGNIFICANTLY. A SHEATH WAS PLACED IN PREPARATION FOR A REBOA PROCEDURE, AND THE BALLOON CATHETER WAS INSERTED AND INFLATED INTO ZONE ONE. THE BALLOON WAS INFLATED (COMPLETE OCCLUSION) FOR A TOTAL OF TWENTY-NINE MINUTES. IT WAS NOTED THAT THE PATIENT DID NOT TOLERATE PARTIAL OCCLUSION. A NEPHRECTOMY, A SPLENECTOMY, AND A LEFT HEMICOLECTOMY WERE PERFORMED. THE PATIENT RECEIVED MULTIPLE UNITS OF BLOOD AND WAS ON PRESSORS; IN ADDITION, THE PATIENT LOST APPROXIMATELY TWENTY-TWO LITERS OF BLOOD. AFTER OPERATING PROCEDURES WERE COMPLETED, THE BALLOON CATHETER WAS DEFLATED AND PREPARED FOR REMOVAL. DURING THE ATTEMPTED REMOVAL OF THE BALLOON CATHETER, THE VASCULAR SURGEON REPORTED MEETING RESISTANCE. HE STATED HE PERFORMED ALL REQUIRED STEPS FOR THE REMOVAL PROCESS AND STILL MET RESISTANCE. THE VASCULAR SURGEON REMOVED THE SHEATH FIRST AND THEN REMOVED THE CATHETER. A FEMORAL ARTERY CUTDOWN AND AN ARTERIOTOMY PRIMARY REPAIR WERE PERFORMED, INCLUDING AN ENDOVASCULAR STENT PLACEMENT. UPON INVESTIGATION OF THIS INCIDENT, ADDITIONAL INFORMATION COULD NOT BE GATHERED AS THE DEVICE WAS NOT RETAINED AND DELIVERED TO PRYTIME FOR ANALYSIS. OVERALL, THERE WAS NO CONFIRMED DEFICIENCY WITH THE PRYTIME PRODUCT EXHIBITED IN THIS CASE. IN ADDITION, THERE IS NO REPORTED OR ALLEGED FAILURE OR DEFICIENCY OF THE PRYTIME CATHETER OR ITS LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831326 PREBOA-PRO CATHETER Catheter, intravascular occluding, temporary MJN PRYTIME MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention