BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH

    MDR report key: 9795624 · Received March 5, 2020

    Report

    Report Number
    3012279212-2020-00001
    Event Type
    Injury
    Date Received
    March 5, 2020
    Report Date
    March 5, 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

    THE ALLEGED INCIDENTS WERE REPORTED TO PRYTIME PERSONNEL VIA WORD OF MOUTH FROM A PHYSICIAN (DR. (B)(6)) NOT INVOLVED IN THE CASES NOR EMPLOYED BY THE HOSPITAL AT WHICH THE ALLEGED INCIDENTS OCCURRED. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PHYSICIAN INVOLVED (DR. (B)(6), (B)(6)) FOR FURTHER DETAIL WITHOUT SUCCESS. THE REPORTED INCIDENTS ALLEGE ACCESS SITE COMPLICATIONS ASSOCIATED WITH THE 7 FR INTRODUCER SHEATH USED TO GAIN FEMORAL ACCESS FOR THE REBOA PROCEDURE. IT IS UNKNOWN WHICH INTRODUCER SHEATH WAS USED AND THERE IS NO ALLEGATION OF SHEATH MALFUNCTION. 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 THE CASES WHERE ALLEGED ACCESS SITE COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    PHYSICIAN ALLEGED VASCULAR REPAIRS WERE REQUIRED TO ADDRESS ACCESS SITE COMPLICATIONS ASSOCIATED WITH USE OF A 7 FR INTRODUCER SHEATH IN 2 OF 8 CASES. IN EACH CASE THE SHEATH WAS USED FOR FEMORAL ACCESS TO INTRODUCE THE PRYTIME ER-REBOA CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258665 ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH INTRODUCER, CATHETER DYB TELEFLEX CP-07711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention