BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIEVER16

    MDR report key: 20087094 · Received August 28, 2024

    Report

    Report Number
    3020347218-2024-00040
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 30, 2024
    Report Date
    November 8, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007130
    PMA / PMN Number
    K211013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS IN TRANSIT TO THE MANUFACTURER. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ADDITIONALLY, A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND NO SIMILAR ISSUES HAVE BEEN REPORTED AGAINST THIS LOT NUMBER IN THE PREVIOUS TWO YEARS. UPON RECEIPT OF THE DEVICE A FULL EVALUATION WILL BE COMPLETED. MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE TREIVER16 (T16) WAS RETURNED TO THE MANUFACTURER AND EVALUATED. VISUAL INSPECTION CONFIRMED THE CATHETER WAS BROKEN APPROXIMATELY 16 INCHES FROM THE DISTAL END OF THE CATHETER. THE PEBAX WAS SEVERED AND THE COIL WAS EXPOSED, BUT STILL INTACT AND CONNECTING THE TWO SEPARATED CATHETER HALVES. A THUMB PRINT 15 INCHES FROM THE DISTAL END AND DAMAGE TO THE DISTAL TIP WERE ALSO OBSERVED. THE BREAK WAS VIEWED CROSS SECTIONALLY, AND IT WAS DETERMINED THE 63D AND 35D PEBAX TRANSITION WAS NOT IN THE CORRECT LOCATION. THIS CAUSED THE 63D AND 35D PEBAX TRANSITION TO BE AT THE SAME LOCATION AS THE BRAID-COIL TRANSITION, WHICH RESULTED IN WEAK TENSILE STRENGTH AT THIS POINT IN THE CATHETER SHAFT. THIS WEAK POINT IN THE CATHETER IN COMBINATION WITH EXCESSIVE FORCE USED, AS EVIDENT BY THE THUMB PRINT NEAR THE BREAK AND DAMAGE ON THE TIP, LIKELY CAUSED THE CATHETER TO BREAK DURING THE PROCEDURE. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ADDITIONALLY, A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND NO SIMILAR ISSUES HAVE BEEN REPORTED AGAINST THIS LOT. THE DEVICE LABELING INCLUDES THE FOLLOWING WARNING STATEMENT: "AVOID USING EXCESSIVE FORCE TO ADVANCE OR RETRACT AGAINST RESISTANCE. IF EXCESSIVE RESISTANCE OCCURS, RETRACT, AND COLLAPSE THE DISTAL DISKS INTO THE CATHETER AND REMOVE THE DEVICE. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE DEVICE OR VESSEL PERFORATION." FOREIGN BODY EMBOLISM IS LISTED AS A POTENTIAL COMPLICATION/ADVERSE EVENT IN THE DEVICE LABELING. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, A 57-YEAR-OLD MALE WITH DEEP VEIN THROMBOSIS (DVT) UNDERWENT DVT THROMBECTOMY USING INARI DEVICES. THE CLOT AGE ESTIMATE WAS 21 DAYS OLD. DURING THROMBECTOMY, THE PATIENT'S RIGHT POPLITEAL VEIN WAS USED AS THE PRIMARY ACCESS SITE. WHILE REMOVING THE TRIEVER16 THROUGH THE POPLITEAL, THE CATHETER BROKE, LEAVING PART OF THE CATHETER IN THE PATIENT'S VEIN WHILE THE PROXIMAL PART OF THE CATHETER WAS REMOVED. THE PHYSICIAN WAS ABLE TO FULLY REMOVE THE SEPARATED PORTION OF THE CATHETER FROM THE PATIENT BY SLOWLY PULLING THE SEPARATED PART FROM THE PATIENT'S BODY THROUGH THE ACCESS SITE. THE PHYSICIAN CONFIRMED THERE WAS NO INJURY TO THE PATIENT'S VESSEL THROUGH FLUOROSCOPY. THE CASE WAS COMPLETED, AND NO FURTHER INTERVENTION WAS REQUIRED. IT WAS ESTIMATED THAT 80% OF THE CLOT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464983 TRIEVER16 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 25-101 23100104 00850291007130

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male