BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEB SL 17 SINGLE LAYER W5-5-2

    MDR report key: 8881416 · Received August 9, 2019

    Report

    Report Number
    2032493-2019-00190
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 11, 2019
    Report Date
    July 12, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006389
    PMA / PMN Number
    P170032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE WEB DEVICE WAS RETURNED INSIDE OF THE VIA17 MICROCATHETER. THE WEB PUSHER WIRE WAS ADVANCED THROUGH THE CATHETER TO FIND THAT NO IMPLANT WAS RETURNED WITH THE DEVICE. THE PUSHER WIRE ADVANCED WITHOUT RESISTANCE. A RESISTANCE READING WAS TAKEN AT THE CONTACTS OF THE PUSHER WIRE AND DISPLAYED A SPORADICALLY HIGH READING. THE CONTACTS OF THE RETURNED DEVICE WERE INSERTED INTO THE TWO ANCILLARY WDCS AND DISPLAYED A RED LIGHT. THE CONTROLLERS WERE TESTED. PCB TEST PROBES WERE INSERTED INTO THE CONTROLLERS TO TEST THE WDC'S RESPONSES. BOTH WDCS FUNCTIONED NORMALLY. NO ABNORMAL RESPONSE WAS OBSERVED FROM EITHER DEVICE WHEN THE TEST PROBES WERE INSERTED. THE CONTACT AREA WAS VIEWED UNDER MAGNIFICATION; THE EXTERNALLY VISIBLE WIRING WAS STILL INTACT, BUT MINOR BENDS WERE NOTED THAT MAY HAVE CONTRIBUTED TO THE INTERMITTENT HIGH RESISTANCE READING. THE REPORTED COMPLAINT IS NON-VERIFIABLE. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE REVIEW OF THE RETURNED PUSHER FOUND INTERMITTENTLY HIGH RESISTANCE READINGS WHICH COULD CAUSE A NON-DETACHMENT SCENARIO. THE CONNECTOR WAS BENT WHICH MAY HAVE CONTRIBUTED TO THE INTERMITTENT READING; THIS DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION. THE TWO DETACHMENT CONTROLLERS WERE RETURNED AND FOUND TO FUNCTION NORMALLY. SINCE THE IMPLANT WAS NOT RETURNED, THE EVALUATION OF THE MONOFILAMENT COULD NOT BE PERFORMED TO DETERMINE IF THE IMPLANT DETACHED USING THE CONTROLLER OR DUE TO TENSILE FORCE. THE EVALUATION OF THE PUSHER ALIGNS WITH THE NON-DETACHMENT THAT WAS DESCRIBED, BUT WITHOUT THE IMPLANT, THE COMPLETE INVESTIGATION CANNOT BE DEFINITIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. THE MANUFACTURING RECORDS WERE REVIEWED. ALL INSPECTION VALUES WERE WITHIN SPECIFICATION AND THERE WERE NO NCR'S OR DEVIATIONS. THE DEVICE WAS RETURNED FOR EVALUATION; THE ANALYSIS IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEB DEVICE WAS BEING USED TO TREAT AN ANEURYSM, BUT WOULD NOT DETACH FROM THE DELIVERY PUSHER. THE WEB WAS REMOVED FROM THE PATIENT, BUT THE IMPLANT DETACHED WITHIN THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674414 WEB SL 17 SINGLE LAYER W5-5-2 WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FG29050-020 18080207 00854111006389

    Patients

    Seq Age Sex Outcome Treatment
    1