BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERTRIEVER REVASCULAZATION DEVICE

    MDR report key: 19456733 · Received June 4, 2024

    Report

    Report Number
    3015531723-2024-00001
    Event Type
    Injury
    Date Received
    June 4, 2024
    Report Date
    June 4, 2024
    Manufacturer
    RAPID-MEDICAL INC.
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ABSENCE OF FORMAL DOCUMENTATION OR A DETAILED INCIDENT REPORT LIMITS THE ABILITY TO DRAW DEFINITIVE CONCLUSIONS ABOUT THE EXACT CAUSE OR CONTRIBUTING FACTORS. IT APPEARS THAT THE DEVICE MAY NOT HAVE BEEN USED IN ACCORDANCE WITH THE RECOMMENDED DEPLOYMENT INSTRUCTIONS, POTENTIALLY LEADING TO THE ISSUE. BASED ON OUR ANALYSIS OF HISTORICAL DATA, THERE DO NOT APPEAR TO BE RECURRING ISSUES WITH VESSEL PERFORATION LINKED TO THE TIGERTRIEVER 13 WHEN USED AS DIRECTED.

    Description of Event or Problem · 0

    DURING A GENERAL FEEDBACK DISCUSSION WITH A PHYSICIAN, IT WAS MENTIONED THAT IN A PAST CASE INVOLVING THE TIGERTRIEVER 13, THE DEVICE MIGHT HAVE BEEN PUSHED FORWARD RATHER THAN STEADILY UNSHEATHED, WHICH COULD HAVE LED TO VESSEL PERFORATION. NO FURTHER DETAILS WERE PROVIDED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665497 TIGERTRIEVER REVASCULAZATION DEVICE TIGERTRIEVER 13 NRY RAPID-MEDICAL INC. TRPP7144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other