BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK COIL-THERMO MECHANICAL

    MDR report key: 11163252 · Received January 13, 2021

    Report

    Report Number
    3008114965-2021-00019
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 22, 2020
    Report Date
    December 22, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704078135
    PMA / PMN Number
    K150319
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UPDATED SECTIONS ON THIS MEDWATCH REPORT: G3, G6, H2, H3, H6, H10 AND H11. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN UNKNOWN -THERMO MECHANICAL COIL WAS ATTEMPTED TO COME OUT FROM THE TIP OF A CONCOMITANT MICROCATHETER (1.9FR CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS) BUT THE MICROCATHETER KICKED BACK. THE PHYSICIAN ATTEMPTED TO RETRACT THE COMPLAINT COIL, BUT IT DETACHED. THE TIP OF THE COMPLAINT COIL WAS INSIDE THE MICROCATHETER THEREFORE, THE COIL WAS REMOVED WITH THE MICROCATHETER TOGETHER. THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER (SAME CATALOG NUMBER/ DIFFERENT LOT NUMBER) AND THE COMPLAINT COIL WAS REPLACED WITH A COMPETITIVE COIL AND THE PROCEDURE CONTINUED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO EXCESSIVE FORCE USED WITH TRYING TO RETRACT THE COIL. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS NO SIGNIFICANT PROLONGATION IN THE PROCEDURE DUE TO THE EVENT. A NON-STERILE UNK COIL-THERMO MECHANICAL WAS RECEIVED INSIDE OF A POUCH WITH A NON-JOHNSON & JOHNSON MICROCATHETER. THE UNK COIL-THERMO MECHANICAL WAS INSPECTED, AND IT WAS FOUND THAT THE DPU IS KINKED AT 25 CM, 32 CM, AND 69 CM FROM PROXIMAL, ALSO IT WAS NOTED THAT THE EMBOLIC COIL IS NOT ATTACHED TO THE DEVICE. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. THE MARKER BAND WAS FOUND AT 84.5 CM FROM THE HUB, THIS SUGGESTS THAT THE LENGTH OF THE EMBOLIC COIL IS WITHIN SPECIFICATION. THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND IT WAS NOTED THAT THE RH IS HEATED, THIS IS RELATED TO THE DETACHED CONDITION OF THE EMBOLIC COIL. THE NON-JOHNSON & JOHNSON MICROCATHETER WAS INSPECTED UNDER X-RAY IN ORDER TO APPRECIATE IF THE EMBOLIC COIL IS STUCK INSIDE IT. DURING THE X-RAY WAS OBSERVED THAT THE COIL IS INSIDE THE MICROCATHETER WITH A STRETCH AND KNOTTED CONDITION. THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. THE CONDITIONS PREVIOUSLY MENTIONED COULD BE RELATED TO THE CUSTOMER COMPLAINT AND APPEAR THAT MIGHT HAVE BEEN CAUSED BY EXCESSIVE FORCE AND/OR HANDLING APPLIED TO THE DEVICE, HOWEVER, THIS CANNOT CONCLUSIVELY DETERMINE. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE CUSTOMER COMPLAINT OF ¿COIL - PREMATURE DETACHMENT-IN MC DURING REMOVAL¿ WAS CONFIRMED. PREMATURE DETACHMENT IS A KNOWN POTENTIAL PRODUCT FAILURE ASSOCIATED WITH THE USE OF THE DEVICE. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES ON THE RETURNED SYSTEM. EXCESSIVE FORCE APPLIED TO A COIL THROUGH REPEATED COIL DEPLOYMENTS OR MANIPULATION CAN INCREASE THE POSSIBILITY OF STRETCHING AND PREMATURE DETACHMENT. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. BASED ON CLARIFICATION FROM THE ACCOUNT RECEIVED ON 16-FEB-2021, THE PRODUCT/LOT NUMBER FOR THE DEVICE INVOLVED/RECEIVED FOR THIS COMPLAINT IS NOT AVAILABLE. THEREFORE, SECTION D1: BRAND NAME WAS UPDATED TO "UNK COIL-THERMO MECHANICAL". SECTION D4; CATALOG WAS UPDATED TO "UNK COIL-THERMO MECHANICAL".

    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 PHONE ¿ (B)(6). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 16MM X 47CM MICRUSFRAME18 COIL (MFR181647, K10015) WAS ATTEMPTED TO COME OUT FROM THE TIP OF A CONCOMITANT MICROCATHETER (1.9FR CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS) BUT THE MICROCATHETER KICKED BACK. THE PHYSICIAN ATTEMPTED TO RETRACT THE COMPLAINT COIL BUT IT DETACHED. THE TIP OF THE COMPLAINT COIL WAS INSIDE THE MICROCATHETER (MC) THEREFORE, THE COIL WAS REMOVED WITH THE MICROCATHETER TOGETHER. THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER (SAME CATALOG NUMBER/ DIFFERENT LOT NUMBER) AND THE COMPLAINT COIL WAS REPLACED WITH A COMPETITIVE COIL AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO EXCESSIVE FORCE USED WITH TRYING TO RETRACT THE MICRUSFRAME18 16MM X 47CM. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS NO SIGNIFICANT PROLONGATION IN THE PROCEDURE DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57372 UNK COIL-THERMO MECHANICAL NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL MFR181647 K10015 10886704078135

    Patients

    Seq Age Sex Outcome Treatment
    1 1.9FR CARNELIAN MARVEL MICROCATHETER.| MICRUSFRAME18 19MM X 50CM.