BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERTRIEVER

    MDR report key: 25298335 · Received May 27, 2026

    Report

    Report Number
    3009957947-2026-00003
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 27, 2026
    Manufacturer
    RAPID-MEDICAL LTD.
    Product Code
    NRY
    PMA / PMN Number
    K203592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS NOTED THAT THE REBAR 18 MICROCATHETER IS NOT AMONG THE MICROCATHETERS VALIDATED FOR USE WITH THE TIGERTRIEVER PER IFU. USE OF NON-VALIDATED ANCILLARY DEVICES MAY HAVE INTRODUCED PROCEDURAL VARIABLES THAT CONTRIBUTED TO THE REPORTED OBSERVATION. ADDITIONALLY, DETAILS REGARDING THE NUMBER OF PASSES PERFORMED, WHETHER RESISTANCE WAS ENCOUNTERED, AND WHETHER ANY TORQUE WAS APPLIED TO THE DEVICE, ALL OF WHICH ARE RELEVANT TO DEVICE INTEGRITY PER THE IFU WARNINGS, WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE DEVICE WAS NOT RETAINED FOLLOWING THE PROCEDURE AND IS THEREFORE UNAVAILABLE FOR PHYSICAL INSPECTION OR INDEPENDENT TECHNICAL EVALUATION. IN THE ABSENCE OF THE DEVICE, THE REPORTED OBSERVATION CANNOT BE INDEPENDENTLY VERIFIED, AND ROOT CAUSE CANNOT BE CONFIRMED. RAPID MEDICAL LTD. IS CONDUCTING AN INVESTIGATION INCLUDING REVIEW OF MANUFACTURING AND QUALITY CONTROL RECORDS FOR THE RELEVANT LOT. NO SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED IN THE CURRENT COMPLAINT TRENDING PERIOD THAT WOULD SUGGEST A SYSTEMIC ISSUE. A SUPPLEMENTAL REPORT WILL BE FILED IF THE INVESTIGATION YIELDS FINDINGS THAT REQUIRE UPDATED ASSESSMENT.

    Description of Event or Problem · 0

    RAPID MEDICAL LTD. RECEIVED A COMPLAINT REPORT ORIGINATING FROM FRANCE REGARDING A TIGERTRIEVER REVASCULARIZATION DEVICE USED DURING A MECHANICAL THROMBECTOMY PROCEDURE. THE DEVICE WAS USED IN CONJUNCTION WITH A REBAR 18 MICROCATHETER AND AN ASAHI CHIKAI 0.014" MICROGUIDEWIRE. FOLLOWING THE PROCEDURE, THE OPERATOR REPORTED OBSERVING WHAT WAS DESCRIBED AS AN ABNORMAL DEFORMATION AT THE DISTAL TIP UPON DEVICE REMOVAL. A VISUAL INSPECTION BY THE REPORTER SUGGESTED POSSIBLE SEPARATION OR UNWINDING OF DISTAL WIRES. NO PATIENT INJURY, NO ADVERSE CLINICAL OUTCOME, AND NO PROCEDURAL COMPLICATION WERE REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344106 TIGERTRIEVER TIGERTRIEVER 21 NRY RAPID-MEDICAL LTD. TRPP3155 250909TR01

    Patients

    Seq Age Sex Outcome Treatment
    1