BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM 71 REPERFUSION CATHETER

    MDR report key: 21827525 · Received April 11, 2025

    Report

    Report Number
    21827525
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 3, 2025
    Manufacturer
    IMPERATIVE CARE, INC.
    Product Code
    NRY
    UDI-DI
    00812212030450
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPERATIVE CARE ZOOM 71 REPERFUSION CATHETER DISTAL FRACTURED LEADING TO RETAINED PORTION IN THE PT'S CERVICAL ICA LOOP TO THE DISTAL RIGHT M1 SEGMENT. THE PT PRESENTED WITH AN ACUTE DISTAL RIGHT M1 CEREBRAL OCCLUSION AND WAS TAKEN FOR MECHANICAL THROMBECTOMY. A ZOOM 88 ASPIRATION CATHETER WAS POSITIONED IN THE PETROUS INTERNAL CAROTID ARTERY FROM A RIGHT GROIN ACCESS PAST A 380 DEGREE VASCULAR LOOP IN THE UPPER RIGHT CERVICAL ICA. THREE IMPERATIVE CARE PUMP ASPIRATION ONLY PASSES WERE PERFORMED USING ZOOM 71 ASPIRATION CATHETER IN COMBINATION WITH ZOOM 35 ASPIRATION CATHETER WHICH WERE UNSUCCESSFUL TO REMOVE THE THROMBUS. THEN, A FOURTH PASS WAS PERFORMED USING A VELOCITY MICRO CATHETER WHICH WAS USED TO DEPLOY A STRYKER 4 MM X 28 MM TREVO NXT STENT RETRIEVER OVER THE THROMBUS, AND THE ZOOM 71 ASPIRATION WAS ADVANCED TO THE THROMBUS INTERFACE, AND THE ZOOM 71 WAS CONNECTED TO PUMP ASPIRATION AFTER REMOVAL OF THE VELOCITY MICRO CATHETER. AFTER TWO MINS, THE RETRIEVER AND ZOOM 71 CATHETER WERE WITHDRAWN TOGETHER. DURING THE PULL BACK OF THE THROMBUS, THERE WAS TENSION GENERATED WHICH RESULTED IN THE ZOOM 71 CATHETER FRACTURING IN THE CERVICAL ICA LOOP. THE RETRIEVER WAS SUCCESSFULLY REMOVED, AND THE PROXIMAL 3/4 OF THE CATHETER WERE REMOVED. THE DISTAL PORTION OF THE CATHETER WAS RETAINED IN THE RIGHT CERVICAL ICA LOOP TO THE DISTAL RIGHT M1 SEGMENT. PRODUCT: ZOOM 1 REPERFUSION CATHETER LOT F2434801 / FG00543-11 BY IMPERATIVE CARE, INC. ATTEMPTS TO RE-ACCESS THE RETAINED CATHETER VIA FRACTURED PORTION WITH THE MICROCATHETER AND MICROWAVE TO REMOVE WITH A RETRIEVER WAS UNSUCCESSFUL AS THE FRACTURED PORTION WAS DEFORMED AND RESTING AGAINST THE WALL. ATTEMPT TO RETRIEVE WITH A SNARE WAS ALSO UNSUCCESSFUL. IT WAS ALSO NOT POSSIBLE TO NAVIGATE 021 AND 027 MICROCATHETER AROUND THE CATHETER BEYOND THE SUPRACLINOID ICA DUE TO INSUFFICIENT ROOM IN THE VESSEL. THERE WAS FLOW AROUND THE CATHETER TO THE RIGHT ICA AND RIGHT ANTERIOR CEREBRAL ARTERY BUT NOT FLOW TO THE RIGHT MIDDLE CEREBRAL ARTERY. I CONSULTED ON CALL VASCULAR SURGEON, AND THERE WAS NO OPEN SOLUTION FROM HIS STANDPOINT GIVEN CIRCUMSTANCES AND HIGH LOCATION. OUTSIDE HOSPITAL PROVIDER ALSO RECOMMENDED LEAVING THE RETAINED FOREIGN CATHETER AS I HAD EXHAUSTED ALL OPTIONS. THERE WAS NO INTRACRANIAL HEMORRHAGE IN THE POST OP HEAD CT AFTER THE MECHANICAL THROMBECTOMY. THE PT WENT ON TO COMPLETE HIS RIGHT MCA INFARCT THE NEXT DAY.

    Description of Event or Problem · 0

    IMPERATIVE CARE ZOOM 71 REPERFUSION CATHETER DISTAL FRACTURE LEADING TO RETAINED PORTION IN THE PATIENT'S CERVICAL ICA LOOP TO THE DISTAL RIGHT M1 SEGMENT. THE PATIENT PRESENTED WITH AN ACUTE DISTAL RIGHT M1 CEREBRAL OCCLUSION AND WAS TAKEN FOR MECHANICAL THROMBECTOMY. A ZOOM 88 ASPIRATION CATHETER WAS POSITIONED IN THE PETROUS INTERNAL CAROTID ARTERY FROM A RIGHT GROIN ACCESS PAST A 360 DEGREE VASCULAR LOOP IN THE UPPER RIGHT CERVICAL ICA. THREE IMPERATIVE CARE PUMP ASPIRATION ONLY PASSES WERE PERFORMED USING ZOOM 71 ASPIRATION CATHETER IN COMBINATION WITH ZOOM 35 ASPIRATION CATHETER WHICH WERE UNSUCCESSFUL TO REMOVE THE THROMBUS. THEN, A FOURTH PASS WAS PERFORMED USING A VELOCITY MICRO CATHETER WHICH WAS USED TO DEPLOY A STRYKER 4 MM X 28 MM TREVO NXT STENT RETRIEVER OVER THE THROMBUS, AND THE ZOOM 71 ASPIRATION WAS ADVANCED TO THE THROMBUS INTERFACE, AND THE ZOOM 71 WAS CONNECTED TO PUMP ASPIRATION AFTER REMOVAL OF THE VELOCITY MICRO CATHETER. AFTER TWO MINUTES, THE RETRIEVER AND ZOOM 71 CATHETER WERE WITHDRAWN TOGETHER. DURING THE PULL BACK OF THE THROMBUS, THERE WAS TENSION GENERATED WHICH RESULTED IN THE ZOOM 71 CATHETER FRACTURING IN THE CERVICAL ICA LOOP. THE RETRIEVER WAS SUCCESSFULLY REMOVED AND THE PROXIMAL 3/4 OF THE CATHETER WERE REMOVED. THE DISTAL PORTION OF THE CATHETER WAS RETAINED IN THE RIGHT CERVICAL ICA LOOP TO THE DISTAL RIGHT M1 SEGMENT. PRODUCT: ZOOM 71 REPERFUSION CATHETER LOT F2434801/FG00543-11 BY IMPERATIVE CARE, INC. ATTEMPTS TO RE-ACCESS THE RETAINED CATHETER VIA FRACTURED PORTION WITH THE MICROCATHETER AND MICROWAVE TO REMOVE WITH A RETRIEVER WAS UNSUCCESSFUL AS THE FRACTURED PORTIONED WAS DEFORMED AND RESTING AGAINST THE WALL. ATTEMPT TO RETRIEVER WITH A SNARE WAS ALSO UNSUCCESSFUL. IT WAS ALSO NOT POSSIBLE TO NAVIGATE 021 AND 027 MICROCATHETER AROUND THE CATHETER BEYOND THE SUPRACLINOID ICA DUE TO INSUFFICIENT ROOM IN THE VESSEL. THERE WAS FLOW AROUND THE CATHETER TO THE RIGHT ICA AND RIGHT ANTERIOR CEREBRAL ARTERY BUT NO FLOW TO THE RIGHT MIDDLE CEREBRAL ARTERY. I CONSULTED ON CALL VASCULAR SURGEON, AND THERE WAS NO OPEN SOLUTION FROM HIS STANDPOINT GIVEN CIRCUMSTANCES AND HIGH LOCATION. OUTSIDE HOSPITAL PROVIDER ALSO RECOMMENDED LEAVING THE RETAINED FOREIGN CATHETER AS I HAD EXHAUSTED ALL OPTIONS. THERE WAS NO INTRACRANIAL HEMORRHAGE IN THE POST OP HEAD CT AFTER THE MECHANICAL THROMBECTOMY. THE PATIENT WENT ON TO COMPLETE HIS RIGHT MCA INFARCT THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006978 ZOOM 71 REPERFUSION CATHETER ZOOM 71 REPERFUSION CATHETER NRY IMPERATIVE CARE, INC. ICRC071137 F2434801 00812212030450

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| L STRYKER TREVO NXT 4 MM X 28 MM STENT RETRIEVER.| SYNCHRO 2 MICROWIRE.| VELOCITY MICROCATHETER .| ZOOM 35 REPERFUSION CATHETER.| ZOOM 88 ASPIRATION CATHETER.