BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE COIL SYSTEM

    MDR report key: 19940449 · Received August 8, 2024

    Report

    Report Number
    3014162263-2024-00052
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 26, 2024
    Report Date
    August 8, 2024
    Manufacturer
    BALT USA
    Product Code
    KRD
    UDI-DI
    00818053029455
    PMA / PMN Number
    K200030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BALT USA REFERENCE # (B)(4). AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED AS DEVICE WAS UNAVAILABLE TO BE RETURN. BASED ON THE PROVIDED INFORMATION, ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. LACK OF DEVICE RETURN PREVENTED DEEPER EVALUATION OF THE REPORTED ISSUE. REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST LOT NUMBER F230800219 HAS BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OF THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "BUENOS D;AS, EN EL (B)(6) SE LIBERÓ UN COIL DE MANERA INESPERADA. ADJUNTO ENV;O COMENTARIOS EL CENTRO PARA QUE SE REPORTADO. ES UN CENTRO QUE UTILIZA HABITUALMENTE EL PRODUCTO POR LO QUE TIENE UN CORRECTO MANEJO DEL DISPOSITIVO. EL COIL SE LIBERO Y QUEDO PARTE EN LA AORTA. SE VE LA ESPIRA QUE QUEDO EN LA ARTERIA BRONQUIAL DESPUES DE RETIRARLO CON UN LAZO Y QUE ROMPIESE. ENV;O INFORMACIÓN Y COMENTARIOS PARA QUE PODÁIS REPORTARLO, · MATERIAL: INTRODUCTOR CORTO 5F RADIOFOCUS TERUMO CATETER SHK 1.0 CORDIS MICROCATERER 1.7 LAMBDA TERUMO · IMAGEN DE LA CAJA CON LOS DATOS DEL COIL LIBERADO PREMATURAMENTE. · IMÁGENES DEL TC POSTERIOR AL PROCEDIMIENTO. SE VE RESTO DEL COIL EN LA AORTA QUE EN LA ESCOPIA NO SE VEIA. · EL COIL SE PURGÓ ANTES DE USARLO, COMO HACEN SIEMPRE. TRANSLATION: AT THE (B)(6) COMPLEX A COIL WAS RELEASED UNEXPECTEDLY. ATTACHED I SEND COMMENTS TO THE CENTER SO THAT IT CAN BE REPORTED. IT IS A CENTER THAT REGULARLY USES THE PRODUCT SO IT HAS CORRECT HANDLING OF THE DEVICE. THE COIL WAS RELEASED AND PART OF IT REMAINED IN THE AORTA. YOU CAN SEE THE COIL THAT REMAINED IN THE BRONCHIAL ARTERY AFTER REMOVING IT WITH A TIE AND BREAKING IT. I SEND INFORMATION AND COMMENTS SO THAT YOU CAN REPORT IT, · MATERIAL: SHORT INTRODUCER 5F RADIOFOCUS TERUMO SHK 1.0 CORDIS CATHETER MICROCATERER 1.7 LAMBDA TERUMO · IMAGE OF THE BOX WITH THE DATA OF THE PREMATURELY RELEASED COIL. · CT IMAGES AFTER THE PROCEDURE. THE REST OF THE COIL IS SEEN IN THE AORTA THAT WAS NOT SEEN IN THE SCOPY. · THE COIL WAS PURGED BEFORE USE, AS THEY ALWAYS DO." UPDATE 12JUL2024 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "1. DID THE PROCEDURE INVOLVE TORTUOUS ANATOMY? NO 2. WILL THE MICROCATHETER BE AVAILABLE FOR RETURN? NO 3. WAS AN ATTEMPT MADE TO DISLODGE THE COIL FROM THE IMPLANT USING THE DISLODGEMENT CONTROLLER? YES 4. WAS THERE ANY INJURY TO THE PATIENT? NO 5. 5. WHAT IS THE PATIENT'S CURRENT CONDITION? THE COIL THAT WAS INITIALLY IN THE AORTA HAS MIGRATED BACK TO THE LOWER LIMBS AS IT WAS RELEASED IN AN UNEXPECTED LOCATION. PATIENT UNDER FOLLOW-UP. 6. 6. WHAT IS THE DATE OF THE INCIDENT? (B)(6) 2024 7. WILL THERE BE A RETURN UNIT? NO RGA WILL BE ISSUED AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532051 PRESTIGE COIL SYSTEM PRESTIGE KRD BALT USA PRES0410CPKPL F230800219 00818053029455

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention