BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSFRAME18 15MM X 50CM

    MDR report key: 10929461 · Received December 1, 2020

    Report

    Report Number
    3008114965-2020-00547
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 9, 2020
    Report Date
    November 10, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704078128
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. SECTION B5: ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE RESISTANCE WAS FELT DURING ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY, A 15MM X 50CM MICRUSFRAME18 COIL (MFR181550, K10194) WAS BEING USED AS A FRAMING COIL. THE DELIVERY WIRE WAS ADVANCED BUT THERE WAS A RESISTANCE FELT AND IT WAS NOT ABLE TO MOVE. THE PHYSICIAN ATTEMPTED TO REMOVE THE 15MM X 50CM MICRUSFRAME18 COIL BUT IT PREMATURELY DETACHED. HOWEVER, THE USER WAS ABLE TO REMOVE THE COIL FROM THE PATIENT. IT WAS REPLACED WITH ANOTHER 15MM X 50CM MICRUSFRAME18 COIL (MFR181550, L16935) BUT THERE WAS ALSO A RESISTANCE FELT. IT WAS ATTEMPTED TO BE RE-SHEATHED BUT THE SHEATH GOT DAMAGED. IT WAS REPLACED WITH ANOTHER COIL AND FRAMING WAS DONE. ANOTHER SMALLER PRESIDIO COIL, COMPETITIVE COILS AND TWO DELTAFILL18 COILS WERE IMPLANTED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE RESISTANCE WAS FELT DURING ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THE 15MM X 50CM MICRUSFRAME18 COIL WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE K10194 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT OF ¿DETACHABLE COIL DELIVERY SYSTEM (DCS) - IMPEDED IN MICROCATHETER WITH NO LOSS OF CEREBRAL TARGET POSITION¿ AND ¿COIL - PREMATURE DETACHMENT-IN MC DURING REMOVAL¿ COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THE INSTRUCTIONS FOR USE (IFU) WARNS THAT IF THE MICROCOIL SYSTEM BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH-PULL MOTION TO FREE IT. IF UNSUCCESSFUL, REMOVE BOTH MICROCATHETER AND MICROCOIL SYSTEM TOGETHER AS A UNIT AND REPLACE WITH NEW DEVICES. THE IFU CAUTIONS THE OPERATOR TO NEVER ADVANCE, WITHDRAW, OR TORQUE THE DELIVERY TUBE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. MANIPULATION OF THE DELIVERY TUBE AGAINST RESISTANCE CAN CAUSE DAMAGE AND/OR PREMATURE DETACHMENT OF THE COIL. ASSIGNMENT OF ROOT CAUSE FOR THE EVENTS REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE AND VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUES. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGESTS THE EVENTS WERE RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT#: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER: THE CUSTOMER CONTACT INFORMATION, INCLUDING NAME, OCCUPATION, PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. COMPONENT CODE: PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE WAS SELECTED. THE DEVICE WAS DISCARDED, THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (B)(4) NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY, A 15MM X 50CM MICRUSFRAME18 COIL (MFR181550, K10194) WAS BEING USED AS A FRAMING COIL. THE DELIVERY WIRE WAS ADVANCED BUT THERE WAS A RESISTANCE FELT AND IT WAS NOT ABLE TO MOVE. THE PHYSICIAN ATTEMPTED TO REMOVE THE 15MM X 50CM MICRUSFRAME18 COIL BUT IT PREMATURELY DETACHED. HOWEVER, THE USER WAS ABLE TO REMOVE THE COIL FROM THE PATIENT. IT WAS REPLACED WITH ANOTHER 15MM X 50CM MICRUSFRAME18 COIL (MFR181550, L16935) BUT THERE WAS ALSO A RESISTANCE FELT. IT WAS ATTEMPTED TO BE RE-SHEATHED BUT THE SHEATH GOT DAMAGED. IT WAS REPLACED WITH ANOTHER COIL AND FRAMING WAS DONE. ANOTHER SMALLER PRESIDIO COIL, COMPETITIVE COILS AND TWO DELTAFILL18 COILS WERE IMPLANTED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394393 MICRUSFRAME18 15MM X 50CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL MFR181550 K10194 10886704078128

    Patients

    Seq Age Sex Outcome Treatment
    1 MICRUSFRAME18 15MM X 50CM