BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRO ELITE SNARE

    MDR report key: 6649676 · Received June 19, 2017

    Report

    Report Number
    2134812-2017-00057
    Event Type
    Injury
    Date Received
    June 19, 2017
    Date of Event
    May 2, 2016
    Report Date
    May 3, 2016
    Manufacturer
    VASCULAR SOLUTIONS, INC
    Product Code
    MMX
    PMA / PMN Number
    K0714757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). PER US: SIMILAR DEVICE IDENTIFIED AS: BRAND NAME: EXPRO ELITRE SNARE. COMMON-DEVICE NAME: SNARE . THE 510(K) 071457. ONE EXPRO ELITE SNARE WAS RETURNED TO VSI FOR EVALUATION. THE LOOP COIL HAD BROKEN JUST DISTAL TO THE INTACT JOINT COIL. AS NO NON-CONFORMITIES WERE FOUND IN THE MANUFACTURING RECORDS AND THE MOST LIKELY ROOT CAUSE IS EXCESSIVE FORCE APPLIED BY THE USER, NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    PHYSICIAN TRIED TO CATCH A LINE OF PORT CATHETER WITH EXPRO ELITE SNARE, BY DOING THIS THE TIP OF THE SNARE WAS LOST IN THE BODY OF THE PATIENT. THE CATHETER WAS RETRIEVED AND TIP OF SNARE WAS LEFT IN PATIENT. PATIENT RECOVERED WITHOUT SYMPTOMS. PERCUTANEOUS INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430370 EXPRO ELITE SNARE SNARE MMX VASCULAR SOLUTIONS, INC 6600-015 581242

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention