BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3202461 · Received July 2, 2013

    Report

    Report Number
    2024168-2013-04144
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. INCORRECT REMOVAL (USE OF THE DELIVERY CATHETER, RATHER THAN, RETRIEVAL CATHETER TO CAPTURE THE FILTER), INCORRECT ANATOMY THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EMBOLIC PROTECTION DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SEPARATION WAS CONFIRMED. THE REPORTED GUIDE WIRE KINK WAS UNABLE TO BE CONFIRMED AS THE BAREWIRE WAS NOT RETURNED. BASED ON A VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EMBOSHIELD NAV6 WAS USED IN THE LEFT POPLITEAL ARTERY DURING ANGIOPLASTY. THE PROCEDURE WENT WELL UNTIL THE DELIVERY CATHETER (DC) WAS USED, RATHER THAN THE RETRIEVAL CATHETER, TO TRY TO REMOVE THE NAV6. A LOOP OCCURRED ON THE NAV6 BAREWIRE AND THE WIRE KINKED FROM THE WIRE MANIPULATION. FORCE WAS APPLIED AND THE DC SEPARATED IN THE PATIENT. THE PHYSICIAN TRIED TO CAPTURE THE SEPARATED SEGMENT USING A PROCEDURAL SHEATH, BUT COULD NOT GET PAST THE LOOP THAT WAS INADVERTENTLY CREATED. A SURGICAL CUT DOWN OF THE COMMON FEMORAL ARTERY WAS REQUIRED TO REMOVE THE SEPARATED SEGMENT OF THE DC. THE PHYSICIAN WAS AWARE OF THIS USER ERROR. THERE WAS APPROXIMATELY A TWO HOUR DELAY IN THE PROCEDURE, BUT THE PATIENT REMAINED STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301198 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention