BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN JETI DISPOSABLE

    MDR report key: 17312031 · Received July 12, 2023

    Report

    Report Number
    2024168-2023-07444
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    December 1, 2022
    Report Date
    July 12, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    QEZ
    PMA / PMN Number
    K213565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3- DATE OF EVENT ESTIMATED AS (B)(6) 2022. D4: THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE PATIENT EFFECTS OF HEMATOMA AND EMBOLIZATION ARE LISTED IN THE JETI ALL IN ONE PERIPHERAL THROMBECTOMY SYSTEM INSTRUCTIONS FOR USE (IFU), AS POSSIBLE ADVERSE EVENTS OF USE OF THE DEVICE. BASED ON THE RESEARCH ARTICLE, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF HEMATOMA AND EMBOLIZATION AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE PROCEDURAL TREATMENTS/INTERVENTIONS ARE RELATED TO CASE CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL PATIENT EFFECT OF DEATH REPORTED IN THE ARTICLE IS CAPTURED UNDER A SEPARATE MEDWATCH REPORT. LITERATURE ATTACHMENTS: ARTICLE: SINGLE-CENTER EXPERIENCE WITH JETI HYDRODYNAMIC THROMBECTOMY SYSTEM FOR ARTERIAL OCCLUSIONS OF THE EXTREMITIESNA

    Description of Event or Problem · 0

    HOLD FOR KP. 7.17.23. IT WAS REPORTED THROUGH A RESEARCH ARTICLE, IDENTIFYING THE JETI ALL IN ONE PERIPHERAL THROMBECTOMY DEVICE, THAT THE DEVICE MAY BE RELATED TO THE FOLLOWING; RE-HOSPITALIZATION, AMPUTATION, EMBOLIZATION, AND ACCESS SITE HEMATOMA. THE PRIMARY OUTCOME FOR SUCCESS WAS DEFINED AS >50% LUMINAL OPENING POST-INTERVENTION. THE ARTICLE CONCLUDES THAT SUCCESS OF THE JETI TO REMOVE THE TARGETED CLOT WAS 83% BY JETI ALONE. REASONS FOR FAILURE WERE ATTRIBUTED TO SMALL ARTERY SIZE AND CHRONIC NATURE OF THE CLOT. ADDITIONAL MODALITIES INCLUDING OPEN THROMBECTOMY, ANGIOPLASTY, AND STENTING WERE USED TO ACHIEVE THE PRIMARY OUTCOME. THE JETI SYSTEM IS AN EFFICACIOUS AND SAFE TOOL FOR USE IN THE TREATMENT OF ACUTE ARTERY OCCLUSION. THERE WAS NO DEVICE MALFUNCTION REPORTED WITH THE USE OF THE JETI ALL IN ONE PERIPHERAL THROMBECTOMY DEVICE. PLEASE SEE ATTACHED ARTICLE 'SINGLE-CENTER EXPERIENCE WITH JETI HYDRODYNAMIC THROMBECTOMY SYSTEM FOR ARTERIAL OCCLUSIONS OF THE EXTREMITIES' FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794925 UNKNOWN JETI DISPOSABLE ASPIRATION THROMBECTOMY CATHETER QEZ ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Disability| H| R