BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM REPERFUSION CATHETER

    MDR report key: 20032657 · Received August 22, 2024

    Report

    Report Number
    3014590708-2024-00028
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 21, 2024
    Report Date
    September 4, 2024
    Manufacturer
    IMPERATIVE CARE. INC
    Product Code
    NRY
    UDI-DI
    00812212030443
    PMA / PMN Number
    K210996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE USER FACILITY REPORT (MW5157734), THE EVENT OCCURRED ON JULY 21, 2024, THE PATIENT'S WEIGHT WAS 78 KG, AND THE BROKEN SEGMENT OF THE ZOOM 35 REMAINS IN THE M3 SEGMENT. AFTER FOLLOWING UP WITH THE INITIAL REPORTER OF THE USER FACILITY REPORT, IT WAS CONFIRMED THAT BOTH THE EVENT DATE AND THE PATIENT WEIGHT LISTED IN THE USER FACILITY REPORT ARE ACCURATE. ADDITIONALLY, THE INITIAL REPORTER CLARIFIED THAT THE PHYSICIAN NOTED THE ZOOM 35 SEGMENT REMAINS IN THE INTRACRANIAL VESSEL.

    Additional Manufacturer Narrative · 0

    TWO ZOOM 35 DEVICES WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE FIRST ZOOM 35 USED IN THE CASE EXHIBITED DAMAGE WITH A SERIES OF INDENTATIONS ON THE EXTERIOR OF THE DISTAL SHAFT. THE PROXIMAL SEGMENT OF THE SECOND ZOOM 35 DEVICE USED IN THE CASE WAS RETURNED FOR INVESTIGATION. INVESTIGATION CONFIRMED THE REPORTED SHAFT BREAK INCLUDING MATERIAL ELONGATION AT THE BREAK LOCATION SUGGESTING AN AXIAL FORCE WAS APPLIED. BASED ON THE COMPLAINT INFORMATION PROVIDED AND WITHOUT THE RETURN OF ADJUNCTIVE DEVICES, THE EXACT ROOT CAUSE FOR THE REPORTED DAMAGE AND BREAK COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, EVIDENCE SUGGESTS THE ZOOM 35 CATHETERS HAD BEEN RETRACTED THROUGH A RESTRICTION RESULTING IN DAMAGE TO THE CATHETER SHAFTS. THE MANUFACTURING RECORDS FOR THE ZOOM 35 CATHETERS WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. PER USER FACILITY REPORT (MW5157734) FILED BY THE HOSPITAL "PATIENT WAS BROUGHT TO THE (B)(6) FOR AN EMERGENCY THROMBECTOMY. AN ASPIRATION CATHETER WAS BEING USED FOR THROMBECTOMY, AND THE ASPIRATION CATHETER BROKE OFF AND REMAINED IN THE M3 SEGMENT. ATTEMPTS WERE MADE TO RECOVER THE CATHETER BUT WERE UNSUCCESSFUL."

    Description of Event or Problem · 0

    AN 84-YEAR-OLD MALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE LEFT M2 SEGMENT. THE PATIENT'S ANATOMY WAS REPORTED TO BE MILDLY TORTUOUS. ACCESS WAS OBTAINED USING THIRD-PARTY (0.096" ID ACCESS CATHETER), WHICH WAS PARKED DISTAL TO THE BIFURCATION. DURING THE FIRST PASS A THIRD-PARTY ASPIRATION CATHETER WAS ADVANCED THROUGH THE ACCESS CATHETER TO THE FACE OF THE CLOT AND ASPIRATION WAS APPLIED. IMAGING SHOWED A MORE DISTAL OCCLUSION REMAINED. THE THIRD-PARTY ASPIRATION CATHETER WAS REMOVED FROM THE PATIENT. DURING THE SECOND PASS, THE PHYSICIAN ADVANCED A ZOOM 35 CATHETER OVER A GUIDEWIRE THROUGH THE THIRD-PARTY ACCESS CATHETER TO THE FACE OF THE CLOT. ASPIRATION WAS APPLIED TO THE ZOOM 35. A PARTIAL CLOT WAS REMOVED. IN THE THIRD PASS, THE SAME ZOOM 35 WAS ADVANCED THROUGH THE ACCESS CATHETER TO THE FACE OF THE CLOT AND ASPIRATION WAS APPLIED. WHILE REMOVING THE ZOOM 35, RESISTANCE WAS FELT AT AN UNKNOWN ANATOMICAL LOCATION. THE ZOOM 35 WAS REMOVED FROM THE PATIENT. IMAGING SHOWED A PARTIAL CLOT WAS REMOVED. INSPECTION OF THE REMOVED ZOOM 35 SHOWED THE OUTSIDE COATING OF THE CATHETER WAS DAMAGED. THE TYPE OF THE DAMAGE WAS NOT PROVIDED. DURING THE FOURTH PASS, A NEW ZOOM 35 WAS ADVANCED THROUGH THE SAME THIRD-PARTY ACCESS CATHETER TO THE CLOT. WHILE RETRACTING THE ZOOM 35, RESISTANCE WAS AGAIN FELT AT THE SAME ANATOMICAL LOCATION. AFTER REMOVING THE ZOOM 35 FROM THE PATIENT, THE PHYSICIAN NOTED THE DISTAL PORTION OF THE ZOOM 35 HAD BROKEN. IMAGING SHOWED THAT THE BROKEN SEGMENT OF THE ZOOM 35 WAS IN THE COMMON CAROTID TO THE M2 BRANCH. THE PHYSICIAN ATTEMPTED TO USE A SNARE TO REMOVE THE BROKEN SEGMENT OF THE ZOOM 35 BUT WAS UNSUCCESSFUL. THE PHYSICIAN PLANNED TO SURGICALLY REMOVE THE BROKEN SEGMENT, HOWEVER THE PATIENT'S FAMILY REFUSED. THE M2 CLOT WAS PARTIALLY REMOVED AND A FINAL TICI 2B SCORE WAS ACHIEVED. IT WAS DETERMINED THAT THE SEPARATED DISTAL END WAS NON-FLOW LIMITING. THE PATIENT WAS REPORTED IN STABLE CONDITION POST PROCEDURE WITHOUT ANY PATIENT SEQUELEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219076 ZOOM REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE. INC ICRC035158 F2410801 00812212030443

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention| O 0.035" GLIDEWIRE| 8.5F SHEATH| ARISTOTLE 0.018"| BMX 0.096"| RED 62| VELOCITY| ZOOM 35