BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROFLEX® ANGIOJET® THROMBECTOMY SET

    MDR report key: 5884441 · Received August 17, 2016

    Report

    Report Number
    2134265-2016-07373
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    May 28, 2016
    Report Date
    July 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K072769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    BRAND NAME ¿ CORRECTED FROM ANGIOJET® SPIROFLEX® TO SPIROFLEX® ANGIOJET® THROMBECTOMY SET. COMMON DEVICE NAME - CORRECTED FROM CATHETER, CORONARY, ATHERECTOMY TO CATHETER, EMBOLECTOMY. PRODUCT CODE ¿ CORRECTED FROM MCX TO DXE. UPN ¿ CORRECTED FROM 105835-002 TO 106553-004. (B)(4). COMPLAINT SOURCE(S) - CORRECTED FROM COMPANY REPRESENTATIVE, CONSUMER, FOREIGN TO COMPANY REPRESENTATIVE, CONSUMER, FOREIGN, HEALTH PROFESSIONAL PMA# OR 510K# - CORRECTED FROM P980037 TO K072769. DEVICE EVALUATED BY MFR.: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED DURING ASPIRATION. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE WHEN THE DEVICE WAS ASPIRATING, THE DEVICE STOPPED WORKING. A MESSAGE TO "RECONNECT SALINE SOLUTION" DISPLAYED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT ARRIVED AT THE HOSPITAL WITH A HEART ATTACK. INFORMATION CLARIFIED THAT ASPIRATION WAS NEVER INITIATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533871 SPIROFLEX® ANGIOJET® THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 106553-004 18944543

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR