BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK COIL-THERMO MECHANICAL

    MDR report key: 10422137 · Received August 18, 2020

    Report

    Report Number
    3008114965-2020-00318
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 30, 2020
    Report Date
    July 30, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 8/31/2020. [ADDITION EVENT INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENT COIL EMBOLIZATION OF A RUPTURED 1.2MM ANEURYSM, THE G3 MINI COIL (CATALOG / LOT NUMBERS UNKNOWN) WAS USED AS THE SECOND COIL. DURING THE ATTEMPT TO DETACH THE COIL WITH THE ENPOWER CONTROL CABLE (ECB00018200 / K10145) AND THE DETACHMENT CONTROL BOX DCB2 (DCB2000500), THE COIL FAILED TO DETACH. THE DETACHMENT BUTTON WAS PRESSED FIVE TIMES. THE COIL BECAME PROTRUDED FROM THE COIL INTRODUCER DURING THE DETACHMENT ATTEMPT, THE PHYSICIAN SUCCESSFULLY REMOVED THE COIL FROM THE PATIENT AND REPLACED WITH A COMPETITOR COIL AND THE PROCEDURE WAS COMPLETED. THE ENPOWER CONTROL CABLE WAS NOT USED TO DETACH SUBSEQUENT COILS NOR WAS IT RE-CHALLENGED. IT WAS REPORTED THAT ALL CONNECTIONS FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN DUE TO INFECTIOUS DISEASE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. E.1: THE INITIAL REPORTER PHONE: (B)(6). THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. THE UNIQUE IDENTIFIER (UDI) IS NOT AVAILABLE. THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENT COIL EMBOLIZATION OF A RUPTURED 1.2MM ANEURYSM, THE G3 MINI COIL (CATALOG / LOT NUMBERS UNKNOWN) WAS USED AS THE SECOND COIL. DURING THE ATTEMPT TO DETACH THE COIL WITH THE ENPOWER CONTROL CABLE (ECB00018200 / K10145), THE COIL FAILED TO DETACH. THE DETACHMENT BUTTON WAS PRESSED FIVE TIMES. THE COIL BECAME PROTRUDED FROM THE COIL INTRODUCER DURING THE DETACHMENT ATTEMPT, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND REPLACED WITH A COMPETITOR COIL AND THE PROCEDURE WAS COMPLETED. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN DUE TO INFECTIOUS DISEASE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. FAILURE TO DETACH IS A KNOWN POTENTIAL PRODUCT ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU CONTAINS SEVERAL CAUTIONS RELATING TO THESE SITUATIONS, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING SHOULD THEY BE ENCOUNTERED DURING USE. PER THE IFU: ¿IF A FAULT LIGHT IS DETECTED, THE SYSTEM READY LIGHT IS NOT ILLUMINATED, OR THERE IS NO DETACHMENT AFTER TWO DETACHMENT ATTEMPTS, REPLACE THE DCB UNIT. IF DETACHMENT STILL DOES NOT OCCUR, CAREFULLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM AND REDEPLOY A NEW MICROCOIL SYSTEM.¿ WITH THE LIMITED INFORMATION PROVIDED IN THE COMPLAINT AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED ISSUE BY THE CUSTOMER CANNOT BE CONFIRMED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE / VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE THAT THE COIL FAILED TO DETACH DURING THE PROCEDURE. BASED ON THE REVIEW OF THE MANUFACTURING DOCUMENTATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT OF FAILURE TO DETACH WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENT COIL EMBOLIZATION OF A RUPTURED 1.2MM ANEURYSM, THE G3 MINI COIL (CATALOG / LOT NUMBERS UNKNOWN) WAS USED AS THE SECOND COIL. DURING THE ATTEMPT TO DETACH THE COIL WITH THE ENPOWER CONTROL CABLE (ECB00018200 / K10145), THE COIL FAILED TO DETACH. THE DETACHMENT BUTTON WAS PRESSED FIVE TIMES. THE COIL BECAME PROTRUDED FROM THE COIL INTRODUCER DURING THE DETACHMENT ATTEMPT, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND REPLACED WITH A COMPETITOR COIL AND THE PROCEDURE WAS COMPLETED. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN DUE TO INFECTIOUS DISEASE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885671 UNK COIL-THERMO MECHANICAL NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 ENPOWER CONTROL CABLE| ENPOWER DCB 2