BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL

    MDR report key: 9607957 · Received January 20, 2020

    Report

    Report Number
    1000121130-2020-00001
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    December 20, 2019
    Report Date
    January 17, 2020
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    DYB
    UDI-DI
    00850004312025
    PMA / PMN Number
    K191190
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN CONFIRMED THE STROKE WAS NOT RELATED TO THE INTRODUCER SHEATH AND THERE ARE NO ALLEGED DEFICIENCIES REGARDING THE DEVICE. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT REPORTED. PER THE IFU, EMBOLISM AND STROKE ARE ASSOCIATED RISKS WITH THE USE OF THIS DEVICE. THE IFU CONTAINS CONTRAINDICATIONS AGAINST USE OF THIS DEVICE FOR THOSE WITH RECENT CEREBRAL VASCULAR ACCIDENTS OR EMBOLIC EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE CATHETER INTRODUCER SHEATH THE PATIENT HAD A STROKE WHILE GOING TRANSSEPTAL. THE PHYSICIAN WAS ABLE TO CONFIRM THAT THE STROKE WAS NOT RELATED TO THE INTRODUCER SHEATH AND THERE ARE NO ALLEGED DEFICIENCIES REGARDING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69616 STEERABLE INTRODUCER SHEATH 8.5F MEDIUM CURL STEERABLE INTRODUCER SHEATH DYB FREUDENBERG MEDICAL, LLC SS085075M UNKNOWN 00850004312025

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R