BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERTRIEVER REVASCULAZATION DEVICE

    MDR report key: 20555142 · Received October 29, 2024

    Report

    Report Number
    3015531723-2024-00003
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 29, 2024
    Manufacturer
    RAPID MEDICAL INC
    Product Code
    NRY
    UDI-DI
    07290015107303
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE DEVICE DISTAL PORTION (DISTAL TO THE CONNECTOR: CABLE MESH AND TIP) WAS MISSING AND APPEARED TO BE DETACHED FROM THE CONNECTOR. OTHER THAN THAT, THE HANDLE STRUCTURE AND MECHANISM WERE FOUND TO BE PROPER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMS NO DEFICIENCIES DURING THE MANUFACTURING OR INSPECTION OF THIS BATCH. THE DEVICE WAS MANUFACTURED ACCORDING TO ALL ESTABLISHED QUALITY STANDARDS AND REGULATORY REQUIREMENTS. PRIOR TO RELEASE, THE DEVICE UNDERWENT THOROUGH QUALITY CONTROL INSPECTIONS AND TESTING, INCLUDING FUNCTIONAL ASSESSMENTS DESIGNED TO VERIFY ITS PERFORMANCE AND INTEGRITY. ALL COMPONENTS OF THE DEVICE, INCLUDING THE HANDLE, MESH, AND CABLE, MET THE REQUIRED SPECIFICATIONS AND PASSED THESE INSPECTIONS WITHOUT ANY INDICATION OF DEFECTS. IN CONCLUSION, BASED ON THE INVESTIGATION AND DOCUMENTATION AVAILABLE, THE TIGERTRIEVER 13 DEVICE WAS FULLY COMPLIANT WITH ALL QUALITY AND PERFORMANCE REQUIREMENTS AT THE TIME OF RELEASE, AND THERE IS NO EVIDENCE OF A MANUFACTURING DEFECT CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE TIGERTRIEVER 13 WAS DELIVERED TO THE INFERIOR RIGHT M2 BRANCH USING A ZOOM 88 AND A 35 MC. PROXIMAL TORTUOSITY WAS OBSERVED IN THE ICA SEGMENT. THE DEVICE WAS UNSHEATHED AND FULLY CLOSED PRIOR TO RETRIEVAL, FOLLOWED BY ASPIRATION. ADDITIONAL SEDATION WAS ADMINISTERED, AND A SECOND RETRIEVAL ATTEMPT WAS MADE. DURING THIS ATTEMPT, THE PATIENT UNEXPECTEDLY MOVED, CAUSING A SUDDEN LOSS OF TENSION ON THE DEVICE. DESPITE THE CHANGE IN TENSION, THE HANDLE WAS FURTHER RETRACTED. UPON REMOVAL OF THE HANDLE AND HYPOTUBE, IT WAS NOTED THAT THE MESH AND CABLE REMAINED INSIDE THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302418 TIGERTRIEVER REVASCULAZATION DEVICE TIGERTRIEVER 13 NRY RAPID MEDICAL INC TRPP7144 231046TL01 07290015107303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability