BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOA CATHETER CONVENIENCE KIT

    MDR report key: 16565279 · Received March 17, 2023

    Report

    Report Number
    3014034613-2023-00004
    Event Type
    Injury
    Date Received
    March 17, 2023
    Date of Event
    February 11, 2023
    Report Date
    March 16, 2023
    Manufacturer
    PRYTIME MEDICAL DEVICES INC.
    Product Code
    OFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRYTIME IS FILING THIS REPORT IN AN ABUNDANCE OF CAUTION DUE TO THE PRESENCE OF AN INTRODUCER SHEATH, WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF A PSEUDOANEURYSM AND HEMATOMA AT THE INSERTION SITE. IT WAS CONFIRMED THAT THE USER FACILITY UTILIZED THE OEM INTRODUCER SHEATH SUPPLIED IN PRYTIME'S CONVENIENCE KIT. ON (B)(6) 2023, PRYTIME WAS NOTIFIED OF THIS CASE. THE CASE INVOLVED A PATIENT THAT WAS PRESENTED WITH A CRUSH INJURY LEAVING THE LEFT LOWER EXTREMITY (LLE) PARTIALLY AMPUTATED AND A RIGHT LOWER EXTREMITY (RLE) CRUSHED. ON ARRIVAL, THERE WERE 2 TOURNIQUETS TO THE LLE AND 1 TO THE RLE. THE TEAM BEGAN RESUSCITATION WITH PLANS TO INTUBATE. EMERGENT INTUBATION HAD TO BE DONE DUE TO THE PATIENT'S NAUSEA/VOMITING. THE SURGEON WAS CONCERNED ABOUT THE PATIENT'S BP RESPONSE. THE PATIENT THEN DEVELOPED BRISK ARTERIAL BLEEDING FROM THE LLE, AND THERE WAS CONCERN FOR CODING. ED PROCEEDED WITH INTUBATING THE PATIENT. A REBOA CATHETER WAS PLACED IN ZONE 3 WITH NO ISSUES NOTED. THE PATIENT'S SBP ABOVE THE BALLOON WAS 150 AND BELOW THE BALLOON WAS 60-70. THE PATIENT TOLERATED INTUBATION WELL AND WENT TO OPERATING ROOM. AFTER THE PROCEDURE WAS COMPLETED AND THE CATHETER WAS REMOVED, AN ANGIOGRAM WAS PERFORMED AND IDENTIFIED A PSEUDOANEURYSM AND HEMATOMA AT THE INSERTION SITE. FOLLOW UP WITH THE SURGEON, INDICATED SURGICAL INTERVENTION WAS REQUIRED AND A STENT WAS PLACED TO THE AREA. PER THE REPORTING SURGEON, THE REBOA MADE IT SAFER TO TAKE THE TOURNIQUETS DOWN, AND IT WAS "NICE TO HAVE IT THERE TO HAVE CONTROL.". UPON INVESTIGATION OF THIS INCIDENT, THE PRESENCE OF THE INTRODUCER SHEATH WITHIN THE BLOODSTREAM COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR. OVERALL, THERE WAS NO CONFIRMED DEFICIENCY WITH THE PRYTIME PRODUCT EXHIBITED IN THIS CASE. THERE WAS NO REPORTED OR ALLEGED FAILURE OF THE KIT COMPONENTS, THE KIT, OR ITS LABELING; NOR A REPORTED OR ALLEGED FAILURE OR DEFICIENCY OF THE PRYTIME CATHETER OR ITS LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548135 REBOA CATHETER CONVENIENCE KIT Catheter introducer kit OFC PRYTIME MEDICAL DEVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention