BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH

    MDR report key: 9892162 · Received March 27, 2020

    Report

    Report Number
    3012279212-2020-00002
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    February 27, 2020
    Report Date
    March 27, 2020
    Manufacturer
    TELEFLEX
    Product Code
    DYB
    PMA / PMN Number
    K970229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRYTIME IS REPORTING THIS MDR BECAUSE IT PROVIDES A CONVENIENCE KIT WITH A 7 FR INTRODUCER SHEATH TO THE USER FACILITY. PRYTIME MEDICAL IS LISTED AS THE LEGAL MANUFACTURER OF THE CONVENIENCE KIT BY VIRTUE OF ITS ROLE AS A REPACKAGER. THE ITEMS WITHIN THE KIT ARE SUPPLIED IN THEIR ORIGINAL SEALED OEM PACKAGING. THE 7 FR INTRODUCER SHEATH INCLUDED IN THIS CONVENIENCE KIT IS MANUFACTURED BY TELEFLEX, INC. IT IS UNKNOWN IF THIS SHEATH WAS USED IN THIS CASE . THE REPORTING PHYSICIAN, DR. (B)(6) COMMUNICATED THAT UAMS HAS PERFORMED APPROXIMATELY 18 REBOA PROCEDURES IN HIGH-RISK OBSTETRICS PATIENTS PRIOR TO 2020 WITHOUT EXPERIENCING ISSUES. SINCE THE START OF THE YEAR, THEY HAVE PERFORMED 3 REBOA PROCEDURES, 2 OF WHICH THEY EXPERIENCED COMPLICATIONS RELATED TO THE INTRODUCER SHEATH. TWO NOTABLE DIFFERENCES ASSOCIATED WITH THE CASES PERFORMED IN 2020 ARE DR. (B)(6), THE TRAUMA SURGEON WHO WAS PREVIOUSLY CALLED UPON TO PHYSICALLY DEPLOY THE ER-REBOA CATHETER IN HIGH-RISK OBSTETRICS PATIENTS IS NO LONGER WORKING AT UAMS. THE PRACTICE FOR HIGH-RISK OBSTETRICS PATIENTS AT UAMS HAS SHIFTED FROM PROPHYLACTIC DEPLOYMENT OF THE ER-REBOA CATHETER TO PROPHYLACTIC DEPLOYMENT OF A 5 FR. MICRO CATHETER, WHICH WOULD BE UPSIZED TO A 7 FR. INTRODUCER SHEATH TO DEPLOY THE ER-REBOA CATHETER IF NECESSARY. IN RESPONSE TO THE ISSUES EXPERIENCED, DR. (B)(6) REPORTED THAT UAMS IS REVERTING TO THE PRACTICE OF PROPHYLACTIC DEPLOYMENT OF THE ER-REBOA CATHETER INSTEAD OF THE 5 FR. MICRO CATHETER FOR HIGH-RISK OBSTETRICS PATIENTS. PRYTIME IS ALSO WORKING WITH UAMS TO SCHEDULE ADDITIONAL ON-SITE TRAINING.

    Description of Event or Problem · 1

    A 5 FR MICRO CATHETER WAS PLACED PROPHYLACTICALLY IN THE CFA OF AN OBSTETRIC PATIENT KNOWN TO BE AT HIGH-RISK OF HEMORRHAGE. THE PATIENT BECAME HYPOTENSIVE AND THE DECISION WAS MADE TO UPSIZE TO A 7 FR INTRODUCER AND PLACE THE ER-REBOA CATHETER EMERGENTLY TO CONTROL HEMORRHAGE. THE BALLOON WAS INFLATED AND HEMORRHAGE CONTROL ACHIEVED. AT SOME POINT DURING THE PROCEDURE A VESSEL DISSECTION WAS DETECTED. WHEN THE ISSUE WAS REPORTED TO PRYTIME MEDICAL, THE REPORTING PHYSICIAN WAS CLEAR THAT THEY BELIEVED THE DISSECTION TO BE RELATED TO USE OF THE 7 FR INTRODUCER SHEATH, SPECIFICALLY WHEN UPSIZING FROM THE 5 FR MICRO CATHETER, AND NOT RELATED TO USE OF ER-REBOA CATHETER WHICH FUNCTIONED AS INTENDED. ULTIMATELY THE PATIENT SURVIVED. OTHER FACTS AND DETAILS OF THE CASE ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354665 ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH INTRODUCER, CATHETER DYB TELEFLEX CP-07711

    Patients

    Seq Age Sex Outcome Treatment
    1