BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 17927909 · Received October 12, 2023

    Report

    Report Number
    3014590708-2023-00030
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 12, 2023
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030443
    PMA / PMN Number
    K210996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPERATIVE CARE, INC. RECEIVED THE PROXIMAL SEGMENT OF THE ZOOM 35 CATHETER FOR INVESTIGATION. INVESTIGATION CONFIRMED SHAFT BREAKAGE AND SUGGESTED THAT AN AXIAL FORCE WAS APPLIED DURING THE PROCEDURE, STRETCHING THE SHAFT MATERIALS PRIOR TO THE DEVICE BREAKING. INVESTIGATION DETERMINED THAT A DISTAL SEGMENT OF THE ZOOM 35 HAD BROKEN OFF FROM THE CATHETER AND WAS NOT RETURNED. INVESTIGATION DEMONSTRATED STRETCHED COIL, AND OUTER JACKET AT THE BREAK LOCATION. ADDITIONALLY, THERE WERE KINKS PRESENT IN THE DISTAL SECTION OF THE CATHETER. FURTHER FOLLOW-UPS WITH THE CUSTOMER DETERMINED THAT THERE WAS NO EVIDENCE OF TORTUOUS ANATOMY, STENOSIS/CALCIFICATION, ABNORMAL INTERACTION BETWEEN ADJUNCTIVE DEVICES, OR USE ERROR CONTRIBUTING TO THE COMPLAINT. BASED ON THE COMPLAINT INFORMATION PROVIDED AND DEVICE INVESTIGATION THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THE ZOOM 35 WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 0

    ACCESS WAS OBTAINED WITH A TRACSTAR ACCESS CATHETER OVER A GUIDEWIRE DURING AN EVALUATION OF A PATIENT WITH IIH (IDIOPATHIC INTRACRANIAL HYPERTENSION). THE TRACSTAR WAS PARKED AT THE INTERNAL JUGULAR VEIN. A ZOOM 35 WAS ADVANCED THROUGH THE TRACSTAR INTO LEFT TRANSVERSE VENOUS SINUS WITHOUT ISSUE. THE ZOOM 35 WAS THEN ADVANCED ACROSS TO THE RIGHT SIGMOID VENOUS SINUS OVER THE GUIDEWIRE. THE GUIDEWIRE WAS REMOVED AND ZOOM 35 HUB WAS CONNECTED VIA TUBING TO THE ACIST CONTRAST INJECTOR MACHINE. NO CONTRAST WAS INJECTED. THE PHYSICIAN INTENDED TO USE THE ZOOM 35 FOR DIAGNOSTIC PURPOSES; TO MEASURE THE VENOUS PRESSURE THROUGHOUT VARIOUS LOCATIONS IN THE VENOUS SINUS ANATOMY. MULTIPLE MEASUREMENTS WERE TAKEN TO LOOK FOR A LARGE CHANGE IN PRESSURES THROUGHOUT THE VENOUS SINUS ANATOMY. WHILE RETRACTING ONLY THE ZOOM 35 BACK TO THE LEFT VENOUS SINUS, THE TREATING PHYSICIAN FELT RESISTANCE. AS A RESULT, THE PHYSICIAN RETRACTED BOTH THE TRACSTAR AND ZOOM 35 TOGETHER AS A SYSTEM. THE PHYSICIAN SAW, UNDER FLUOROSCOPY, THAT THE INNER COIL OF THE ZOOM 35 HAD UNRAVELED, AND IT WAS "TRAILING" THE ZOOM 35 TIP. THE ENTIRE ZOOM 35 WAS REMOVED WITH THE TRACSTAR, AND BOTH CATHETERS WERE REMOVED TOGETHER FROM THE PATIENT WITHOUT ANY PATIENT COMPLICATIONS. THERE WAS NO MAJOR TORTUOSITY OR PRESENCES OF STENOSIS/CALCIFICATION OBSERVED, AND THERE WERE NO PRE-EXISTING IMPLANTS PRESENT. THERE WERE NO KINKS OBSERVED ON THE TRACSTAR OR ZOOM 35, AND NO ISSUES WITH THE OTHER DEVICES. A NEW TRACSTAR AND A NEW ZOOM 35 WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ANY PATIENT COMPLICATIONS. AS A PRECAUTIONARY STEP, THE PHYSICIAN PERFORMED A COMPLETE SCAN OF THE PATIENT, AND NO FOREIGN OBJECTS WERE OBSERVED. NO PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749104 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC035158 F2304201 00812212030443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GLIDEWIRE 0.035"| PENUMBRA SELECT CATHETER| SYNCHRO SELECT .014"| TRACSTAR 95