BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREBOA-PRO CATHETER

    MDR report key: 12661745 · Received October 19, 2021

    Report

    Report Number
    3012279212-2021-00003
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 19, 2021
    Manufacturer
    PRYTIME MEDICAL DEVICES INC.
    Product Code
    MJN
    PMA / PMN Number
    K200459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER AND SHEATH INVOLVED IN THIS MDR WERE RECEIVED AND EVALUATED BY PRYTIME MEDICAL. THE CATHETER AND BALLOON WERE TESTED AND FUNCTIONED AS INTENDED. A SMALL BUNCHING OF THE BALLOON MATERIAL WAS APPARENT AT THE DISTAL END OF THE BALLOON. IN ADDITION, THE SHEATH LENGTH WAS NOTICEABLY COMPRESSED FROM 11 CM TO 7.62 CM. IT IS BELIEVED THAT PLACING THE PATIENT IN THE LITHOTOMY POSITION AFTER SHEATH INTRODUCTION AND PRIOR TO CATHETER INSERTION CREATED A TORTUOUS PATH FOR THE BALLOON DURING THE BALLOON INSERTION AND REMOVAL PROCESS. THE TORTUOUS PATH MAY HAVE CONTRIBUTED TO THE BUNCHING OF THE BALLOON MATERIAL, WHICH THEN MADE IT DIFFICULT TO PULL THE CATHETER BACK THROUGH THE SHEATH. WITHDRAWING THE CATHETER WHILE THE SHEATH IS BENT, I.E. WHEN THE PATIENT IS IN LITHOTOMY POSITION, SHOULD BE AVOIDED AND IS LIKELY THE REASON FOR THE SHEATH COMPRESSION IN LENGTH AND SUBSEQUENT REMOVAL ISSUES.

    Description of Event or Problem · 1

    ON SEPTEMBER 21, 2021 PRYTIME WAS INFORMED THAT A SURGICAL RESIDENT MET RESISTANCE WHEN REMOVING A PREBOA-PRO CATHETER FROM AN INTRODUCER SHEATH IN A PATIENT DIAGNOSED WITH PLACENTAL PERCRETA DURING PREGNANCY, PLACING HER AT HIGH RISK OF EMERGENT HEMORRHAGE DURING DELIVERY. THE CATHETER FUNCTIONED AS INTENDED FOR HEMORRHAGE CONTROL AND THE BABY WAS SUCCESSFULLY DELIVERED. PATIENT WAS PUT IN THE LITHOTOMY POSITION AFTER THE INTRODUCER SHEATH HAD BEEN PLACED. A SUCCESSFUL DISSECTION OF THE EXTRAUTERINE PLACENTA OFF THE COMMON FEMORAL ARTERY WITH A LIGATURE WAS PERFORMED AS PART OF THE PROCEDURE. WHILE THE PATIENT WAS STILL IN THE LITHOTOMY POSITION, THE RESIDENT ATTEMPTED REMOVAL OF THE CATHETER AND MET RESISTANCE. THE RESIDENT ATTEMPTED TROUBLESHOOTING THE REMOVAL BY RE-INSERTING, FULLY INFLATING, AND THEN PROPERLY DEFLATING BUT STILL MET RESISTANCE. THIS TROUBLESHOOTING METHOD WAS ATTEMPTED AGAIN; HOWEVER, THE CATHETER CONTINUED TO MEET RESISTANCE UPON PULLING. THE ATTENDING TRAUMA SURGEON MADE THE DECISION TO PULL THE SHEATH FROM THE PATIENT WITH THE CATHETER IN PLACE AND PRESSURE WAS HELD ON THE ACCESS SITE. IT IS BELIEVED THAT WITHDRAWING THE BALLOON THROUGH THE SHEATH WHILE IN THE LITHOTOMY POSITION LED TO THE DIFFICULTY OF CATHETER REMOVAL. AFTER THE SURGICAL TEAM CLOSED THE PATIENT, A POST-OPERATIVE ULTRASOUND REVEALED A CLOT IN THE COMMON FEMORAL ARTERY. A SURGICAL THROMBECTOMY WAS PERFORMED WHICH CONSISTED OF USING A 4 CM SUPERFICIAL INCISION AND A 2 MM ARTERIOTOMY TO REMOVE THE CLOT. PER THE TRAUMA SURGEON, THE DISSECTION OF EXTRAUTERINE PLACENTA OFF THE COMMON FEMORAL ARTERY WITH A LIGATURE MAY HAVE CONTRIBUTED TO THE CLOT; HOWEVER, DIFFICULTY REMOVING THE CATHETER MAY HAVE ALSO BEEN A FACTOR. THE PATIENT'S CONDITION STABILIZED WITH ADEQUATE PULSES AND BLOOD FLOW, AND ULTIMATELY THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559414 PREBOA-PRO CATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, PRODUCT CODE: MJN MJN PRYTIME MEDICAL DEVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention