BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR CX 35 DETACHABLE

    MDR report key: 19057482 · Received April 8, 2024

    Report

    Report Number
    2032493-2024-00277
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    December 3, 2023
    Report Date
    June 11, 2024
    Manufacturer
    MICROVENTION
    Product Code
    KRD
    UDI-DI
    00812636021065
    PMA / PMN Number
    K151358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS STATED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RETURNED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE DEVICE IS RECEIVED AT A LATER DATE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT ADDRESSES THE THIRD COIL. THE SECOND COIL IS REFERENCED UNDER MFR REPORT# 2032493-2024-00276. THE CUSTOMER PROVIDED SIX RADIOGRAPHIC IMAGES FOR REVIEW: THIS IS THE SAME PATIENT AND IMAGES AS P24-1590. SIX RADIOGRAPHIC IMAGES ARE SUBMITTED, LABELED IMG_1395 TO IMG_1400. THEY ARE ALL SINGLE SHOT UNSUBTRACTED AP RADIOGRAPHS, WITHOUT CONTRAST, CENTERED OVER THE LEFT ABDOMEN; THE LAST IMAGE IS A SUBTRACTED DSA WITH NO CONTRAST. THERE ARE 2 SMALL COIL BALLS TO THE LEFT OF T-11. THE INITIAL IMAGES SHOW A 5 F CATHETER IN THE MID-SPLENIC ARTERY, TO THE LEFT OF T-11. AN INTACT COIL MASS IS SEEN MORE DISTALLY IN THE SPLENIC ARTERY. HOWEVER, FROM THE COIL MASS BACK TO AND INTO THE VISIBLE 5 F CATHETER, THE COIL IS DAMAGED AND STRETCHED/UNRAVELED. THE PUSHER WIRE POSITION IS NOT ON THE RADIOGRAPHS. LATER ON, THE 5 F CATHETER HAS BEEN PULLED BACK INTO THE AORTA. THE STRETCHED COIL EXTENDS TO AND INTO THE 5 F CATHETER. AGAIN, THE PUSHER WIRE POSITION IS NOT ON THE RADIOGRAPH. THESE IMAGES DO NOT EXPLAIN WHY THE COIL PROBLEMS OCCURRED." THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE IMPLANT COILS STRETCHED AT THE PROXIMAL SECTION, WHICH IS CONSISTENT WITH THE ALLEGED PRODUCT ISSUE. THE UNIT DID NOT PASS CONTINUITY AND RESISTANCE TESTING. FURTHER INSPECTION OF THE PUSHER FOUND THE GREEN LEAD WIRE BROKEN AT THE PROXIMAL SOLDER JOINT, WHICH IS CONSISTENT WITH NON-DETACHMENT. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING RETRACTION FORCES OVER SPECIFICATION. THE MICROCATHETER USED IN THE PROCEDURE WAS NOT RETURNED, SO THE INVESTIGATION COULD NOT DETERMINE IF IT HAD CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN WAS EMBOLIZING A SPLENIC ARTERY. THE PHYSICIAN HAD IMPLANTED TWO 0.018 COILS AND BEGAN TO IMPLANT A 0.035" COIL, USING A CATHETER. THE FIRST COIL WENT WELL. THE SECOND COIL HAD TROUBLE RELEASING DURING ACTIVATION WITH THE CONTROLLER AND STRETCHED. THE PHYSICIAN THEN LET GO OF THE COIL AND HAD TO CATCH IT WITH A "MOSQUITO" AND BROUGHT IT WITH THE MICROPHONE BECAUSE THE COIL WAS INSIDE THE CATHETER. THE COIL COULD NOT BE RELEASED, AND HE TRIED TO RELEASE IT WITH SERUM. THE COIL LOST ITS SHAPE, A THREAD REMAINED. THE THIRD COIL HAD THE SAME BEHAVIOR AS THE SECOND. IT WAS NOT POSSIBLE TO IDENTIFY WHICH COIL WAS THE SECOND AND WHICH WAS THE THIRD. THE TWO COILS WERE NOT USED AND WERE REPLACED WITH ADDITIONAL COILS TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT. THIS IS REPORT 2 OF 2 AND ADDRESSES THE THIRD COIL. THIS DEVICE WAS USED DURING THE SAME PROCEDURE AS THE DEVICE REPORTED IN MANUFACTURE REPORT NUMBER 2032493-2024-00276.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED, THAT IT IS UNKNOWN WHICH COIL WAS REMOVED WITH THE SNARE DEVICE. THE UNITS DISPLAYED IN THE IMAGES AS IF SOMETHING OCCURRED WITH THE GUIDE OF THE COIL AND THE SHAPE DISPLAYED LIKE WAVES INSTEAD OF A STRAIGHT SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96469 AZUR CX 35 DETACHABLE VASCULAR EMBOLIZATION DEVICE KRD MICROVENTION 45-750824 0000133034 00812636021065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention