BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6

    MDR report key: 18592082 · Received January 26, 2024

    Report

    Report Number
    2024168-2024-01133
    Event Type
    Injury
    Date Received
    January 26, 2024
    Date of Event
    December 14, 2023
    Report Date
    December 12, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NTE
    PMA / PMN Number
    K191173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. RESISTANCE DURING ADVANCEMENT RESULTING IN TIP DAMAGE, DIFFICULTY REMOVING, AND MATERIAL SEPARATION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE INVESTIGATION DETERMINED THAT THE REPORTED RESISTANCE DURING ADVANCEMENT, TIP DAMAGE, DIFFICULTY REMOVING AND MATERIAL SEPARATION OF THE BAREWIRE TIP RESULTING IN UNEXPECTED MEDICAL INTERVENTION TO RETRIEVE THE SEPARATED TIP APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION, IT IS LIKELY THAT THE RESISTANCE DURING ADVANCEMENT WAS DUE TO ANATOMICAL CONDITIONS. ADDITIONALLY, IT IS LIKELY THAT WHILE ADVANCING AGAINST RESISTANCE, THE TIP BECAME STUCK CAUSING DAMAGE AND DIFFICULTY REMOVING ULTIMATELY RESULTING IN TIP SEPARATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. D1 CORRECTION: BRAND NAME UPDATED D2A CORRECTION: COMMON DEVICE NAME UPDATED D3 CORRECTION: NAME, ADDRESS UPDATED D4 CORRECTION: LOT NUMBER UPDATED FROM 3032861 TO UNKNOWN D4 CORRECTION: PRIMARY UDI NUMBER UPDATED TO (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY REVEALED NO OTHER SIMILAR COMPLAINTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THAT THE REPORTED RESISTANCE DURING ADVANCEMENT, TIP DAMAGE, DIFFICULTY REMOVING AND MATERIAL SEPARATION OF THE BAREWIRE TIP RESULTING IN UNEXPECTED MEDICAL INTERVENTION TO RETRIEVE THE SEPARATED TIP APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION, IT IS LIKELY THAT THE RESISTANCE DURING ADVANCEMENT WAS DUE TO ANATOMICAL CONDITIONS. ADDITIONALLY, IT IS LIKELY THAT WHILE ADVANCING AGAINST RESISTANCE, THE TIP BECAME STUCK CAUSING DAMAGE AND DIFFICULTY REMOVING ULTIMATELY RESULTING IN TIP SEPARATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON AND INTERNAL CAROTID ARTERY. THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ATTEMPTED TO BE USED IN A PROCEDURE; HOWEVER, RESISTANCE WAS NOTED DURING ADVANCEMENT DUE TO THE ANATOMY AND THE TIP OF THE BAREWIRE BECAME BENT. THEREFORE, THE EPS WAS REMOVED AND DURING REMOVAL THE TIP BECAME STUCK WITH THE SHEATH AND SEPARATED. THE TIP WAS ABLE TO BE CAPTURED WITH A BALLOON INSIDE THE CATHETER AND THE CATHETER, SHEATH AND TIP OF THE BAREWIRE WERE REMOVED FOR THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838863 EMBOSHIELD NAV6 TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE ABBOTT VASCULAR INC. 22443-19 3032861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention