BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERTRIEVER

    MDR report key: 12794177 · Received November 11, 2021

    Report

    Report Number
    3015531723-2021-00007
    Event Type
    Injury
    Date Received
    November 11, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 11, 2021
    Manufacturer
    RAPID MEDICAL LTD.
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE DEVICE WAS DISCARDED; THEREFORE, NO TECHNICAL INVESTIGATION CAN BE PERFORMED. SINCE THERE ARE NO IMAGES OR VIDEOS FROM THE PROCEDURE EXCLUDING A SINGLE PICTURE OF THE RETRIEVED DEVICE, THE ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE. FROM THE INFORMATION PROVIDED, IT APPEARS THAT THE USER RETRIEVED THE DEVICE IN ITS OPEN STATE AGAINST SIGNIFICANT RESISTANCE WHICH SUBSEQUENTLY RESULTED IN A DISSECTION OF THE ARTERY. IN ADDITION, SINCE THE DEVICE WAS NOT DEFLATED WHILE WITHDRAWN WITH THE MICROCATHETER INTO THE GUIDE CATHETER, THE MESH WAS COLLAPSED INSIDE THE GUIDE CATHETER. WITHDRAWAL DIFFICULTY FROM VESSEL AND DISSECTION OR PERFORATION ARE WELL-KNOWN POTENTIAL PROCEDURAL COMPLICATIONS AS INDICATED IN THE LABELING. THE TIGERTRIEVER INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: "SLOWLY WITHDRAW THE MICROCATHETER AND THE TIGERTRIEVER DEVICE AS A UNIT TO THE GUIDE CATHETER WHILE APPLYING VIGOROUS ASPIRATION TO THE GUIDE CATHETERS WITH A 60 CC SYRINGE UNTIL THE DEVICE AND MICROCATHETER ARE NEARLY WITHDRAWN FROM THE GUIDE CATHETER. IF NEEDED, ADJUST THE SIZE OF THE DEVICE DURING THE RETRIEVAL UNDER FLUOROSCOPIC VISUAL CONTROL". IN ADDITION, THE IFU ALSO CAUTIONS THE USER TO NEVER WITHDRAW THE DEVICE AGAINST SIGNIFICANT RESISTANCE: "DO NOT RETRIEVE THE DEVICE WHEN ENCOUNTERING EXCESSIVE RESISTANCE. INSTEAD, RESHEATH THE DEVICE INTO THE MICROCATHETER AND THEN REMOVE THE ENTIRE SYSTEM UNDER ASPIRATION. IF RESISTANCE IS ENCOUNTERED DURING RESHEATING, DISCONTINUE AND REMOVE THE ENTIRE SYSTEM UNDER ASPIRATION". DHR REVIEW PRESENTED NO ISSUES , THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED LATER.

    Description of Event or Problem · 0

    A REPORT FROM THE FIELD INDICATED THAT DURING MECHANICAL THROMBECTOMY WITH THE TIGERTRIEVER 17 DEVICE A RUPTURE OF THE ARTERY OCCURRED DURING THE RETRIEVAL WHICH LED TO IT HAVING TO BE COILED OFF. ACCORDING TO THE PHYSICIAN, THE DEVICE WAS DISCARDED, SINCE IT WAS STUCK WITH THE MICROCATHETER INSIDE THE GUIDING CATHETER. A PICTURE OF THE RETRIEVED DEVICE DEMONSTRATES THAT THE DEVICE WAS FOLDED, HOWEVER, NO ADDITIONAL IMAGES OR VIDEOS FROM THE PROCEDURE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699379 TIGERTRIEVER TIGERTRIEVER 17 NRY RAPID MEDICAL LTD. TRPP7166 211003TS01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention