BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 24325454 · Received February 12, 2026

    Report

    Report Number
    3014590708-2026-00006
    Event Type
    Death
    Date Received
    February 12, 2026
    Date of Event
    November 8, 2025
    Report Date
    February 12, 2026
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    PMA / PMN Number
    K242672
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED: B1: ADVERSE EVENT OR PRODUCT PROBLEM G6: TYPE OF REPORT. H2: IF FOLLOW-UP, WHAT TYPE? H11: ADDITIONAL MANUFACTURER NARRATIVE. FOLLOWING AN INTERNAL REVIEW CONDUCTED ON MARCH 17, 2026, AN INADVERTENT ENTRY ERROR WAS IDENTIFIED IN SECTION B1, "ADVERSE EVENT OR PRODUCT PROBLEM." THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THE B1 ENTRY AND REFLECT THE APPROPRIATE SELECTION.

    Additional Manufacturer Narrative · 0

    THE ZOOM 55 DEVICE WAS DISCARDED AND NOT RETURNED FOR INVESTIGATION. NO MALFUNCTION WAS NOTED ON THE ZOOM 55. THE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED THE PRODUCT MET DESIGN AND MANUFACTURING SPECIFICATIONS. BASED ON THE COMPLAINT INVESTIGATION, THE EXACT ROOT CAUSE FOR THE PERFORATION, HEMORRHAGE AND DEATH CANNOT BE CONFIRMED. THE INFORMATION PROVIDED DID NOT MAKE ANY INDICATION THAT THE ZOOM 55 DIRECTLY CAUSED THE REPORTED ADVERSE EVENT. AS MULTIPLE DEVICES WERE INVOLVED IN THE REPORTED EVENT, A RELATED MDR WAS SUBMITTED FOR THE SAME PATIENT AND INCIDENT UNDER REFERENCE NUMBER 3014590708-2026-00005.

    Description of Event or Problem · 0

    THROMBECTOMY WAS PERFORMED FOR AN M1 STROKE. THE PHYSICIAN UTILIZED A THIRD-PARTY WIRE, ZOOM SIM AND ZOOM 88. THE 88 REMAINED LOW IN THE CERVICAL ICA WHILE A ZOOM 71, THIRD-PARTY MICROCATHETER AND THIRD-PARTY NEURO WIRE WERE ADVANCED TO THE CLOT. MANUAL ASPIRATION WAS PERFORMED WITH A SYRINGE THROUGH ZOOM 71 WHEN THE PHYSICIAN FELT RESISTANCE AND SLIPPING OF THE ZOOM 88 AND THE PHYSICIAN LOST ACCESS. PHYSICIAN REMOVED EVERYTHING INCLUDING THE ZOOM 88. HE WENT BACK UP WITH A THIRD-PARTY ACCESS CATHETER AND A NEW ZOOM 71 AND WAS ABLE TO OPEN THE M1 SUCCESSFULLY. THERE WERE DISTAL BLOCKAGES THAT HE ATTEMPTED TO REACH WITH A ZOOM 55 UNSUCCESSFULLY, AT WHICH POINT THE PROCEDURE WAS STOPPED. POST PROCEDURE, IT WAS NOTICED THAT THE ZOOM 88 WAS KINKED MID-SHAFT AND THE ORIGINAL ZOOM 71 WAS KINKED NEAR THE DISTAL TIP. THE KINKS ON THE ZOOM CATHETERS WERE ATTRIBUTED TO THE PATIENT'S TORTUOUS ANATOMY AND DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. THE THIRD-PARTY FEMORAL SHEATH WAS ALSO KINKED AT THE GROIN ACCESS SITE. POST PROCEDURE, AN INTERCRANIAL PERFORATION WAS IDENTIFIED. ADDITIONALLY, POST PROCEDURE A RLE (RIGHT LOWER EXTREMITY) ISCHEMIA WAS NOTED, AND A HEAD CT WAS PERFORMED WHICH CONFIRMED A LARGE 8-9MM PARENCHYMAL HEMORRHAGE WITH IVH (INTRAVENTRICULAR HEMORRHAGE) AND SAH (SUBARACHNOID HEMORRHAGE). THE PHYSICIAN DID NOT SPECIFY A CAUSE FOR THE PERFORATION AND NO INTERVENTION WAS PERFORMED TO TREAT THE PERFORATION. PATIENT DEATH OCCURRED ON (B)(6) 2025 AND CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389503 ZOOM REPERFUSION CATHETER ZOOM REPERFUSION CATHETER NRY IMPERATIVE CARE INC. ICRC055137 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other| D FEMORAL SHEATH.| MICROCATHETER.| NEURO WIRE.| NEURON MAX.| ZOOM 71.| ZOOM 88.| ZOOM SIM.