BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 14053393 · Received April 8, 2022

    Report

    Report Number
    3014590708-2022-00007
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 8, 2022
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030443
    PMA / PMN Number
    K210996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOOM 35 CATHETER WAS RETURNED FOR INVESTIGATION. THE INSPECTION OF THE COMPLAINT DEVICE CONFIRMED THAT A 9.6CM PORTION OF THE DISTAL END OF THE ZOOM 35 WAS PROTRUDING FROM THE DISTAL TIP OF THE ZOOM 55. AN ATTEMPT WAS MADE TO REMOVE THE ZOOM 35 FROM THE ZOOM 55 BUT WAS UNSUCCESSFUL DUE TO AN INTERFERENCE CONDITION BETWEEN THE TWO DEVICES. THE BREAK LOCATION WAS NOTED TO BE AT ONE OF THE CATHETER JUNCTIONS. THERE WAS A SMALL SECTION OF STRETCHED INNER LINER VISIBLE ON THE REMAINDER OF THE PROXIMAL END OF THE ZOOM 35. IN ADDITION, A TORN OUTER JACKET AND EXPOSED METAL WERE NOTED. A STRETCHED SECTION OF THE ZOOM 55 WAS FOUND AT THE STRAIN RELIEF OF THE LUER THAT APPEARED TO HAVE BEEN TWISTED. THE TIP OPENING OF THE ZOOM 55 WAS OBSERVED TO BE SLIGHTLY OVALIZED. BASED ON THE INFORMATION PROVIDED, THE PHYSICIAN FELT RESISTANCE WHEN RETRACTING ZOOM 35. PER ZOOM 35 INSTRUCTIONS FOR USE: "DO NOT ADVANCE OR WITHDRAW THE ZOOM CATHETER OR ACCESSORY/ADJUNCTIVE DEVICES AGAINST RESISTANCE WITHOUT CAREFUL ASSESSMENT OF CAUSE UNDER FLUOROSCOPY. IF THE CAUSE CANNOT BE DETERMINED, WITHDRAW ALL DEVICES AS A SINGLE UNIT. EXCESSIVE MANIPULATION AND TORQUING THE DEVICE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE VASCULATURE OR THE DEVICE" AND "DO NOT USE KINKED DEVICES." THE MANUFACTURING RECORDS OF THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY ISSUES PERTAINING TO DESIGN, MANUFACTURING, OR QUALITY.

    Description of Event or Problem · 0

    THE PATIENT WAS BEING TREATED FOR AN OCCLUSION AT THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) M2 SEGMENT. ZOOM 35 AND ZOOM 55 WERE REMOVED FROM PACKAGING AND FLUSHED. A GUIDEWIRE WAS FLUSHED AND LOADED INTO ZOOM 35. ZOOM 35 WAS INSERTED INTO ZOOM 55, AND THE ASSEMBLY WAS PLACED IN HEPARINIZED SALINE. ACCESS WAS SUCCESSFULLY GAINED WITH ZOOM 88. WHILE ACCESS WAS BEING OBTAINED, ZOOM 35 AND ZOOM 55 ASSEMBLY WAS MOVED TO THE STERILE FIELD FOR A SHORT PERIOD OF TIME. WHEN INSERTING THE ZOOM 35 AND ZOOM 55, THE PHYSICIAN NOTED THE ASSEMBLY FELT "STICKY". THE ASSEMBLY WAS ADVANCED THROUGH THE VASCULATURE TO THE CLOT. WHEN THE PHYSICIAN TRIED TO RETRACT ZOOM 35 INTO ZOOM 55, HE FELT RESISTANCE. ADDITIONAL EFFORT WAS MADE TO PULL THE ZOOM 35. THE CATHETER FRACTURED AND PROXIMAL PORTION OF THE ZOOM 35 WAS REMOVED. THE DISTAL END OF THE ZOOM 35 WAS IN THE ZOOM 55 AND BOTH CATHETERS WERE REMOVED AS ONE UNIT. THERE WAS NO INTERVENTION REQUIRED AS THERE WAS NO FOREIGN MATERIAL LEFT IN THE BODY. THE PHYSICIAN CONTINUED THE CASE WITH A NEW ASSEMBLY OF ZOOM 71 AND ZOOM 35. THE CASE WAS SUCCESSFULLY COMPLETED WITH ONE PASS. THE PATIENT ACHIEVED TICI 3 RESULT AND NIHSS SCORE WENT FROM 17 PRE-PROCEDURE TO 1 THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160530 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC035158 F2200302 00812212030443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARISTOTLE 18 GUIDEWIRE.| ZOOM 55.| ZOOM 71.| ZOOM 88.