BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LRS INSTANT DETACHER

    MDR report key: 14005500 · Received April 4, 2022

    Report

    Report Number
    2029214-2022-00572
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 18, 2022
    Report Date
    May 11, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    HCG
    PMA / PMN Number
    K060747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #704922246:¿ EQUIPMENT USED: VIS (M-78210), AXIUM COIL (MODEL: QC-2-4-3D LOT: A135092) ¿ DRAWING(S) REFERENCED: NONE ¿ AS FOUND CONDITION: THE INSTANT DETACHER WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, WITHIN A PRIMARY PLASTIC ZIPLOC POUCH, AND WITHIN A SECONDARY PLASTIC ZIPLOC POUCH. ¿ VISUAL INSPECTION/DAMAGE LOCATION DETAILS: VISUAL INSPECTION OF THE ASSEMBLED INSTANT DETACHER SHOWED NO DEFECTS. ¿ TESTING/ANALYSIS: ONE IN-HOUSE AXIUM COIL WAS THEN SELECTED FOR TESTING WITH THE INSTANT DETACHER. NO DIFFICULTY WAS EXPERIENCED I NSERTING THE PUSHER INTO THE INSTANT DETACHER, AND THE LOAD INDICATOR WAS NOT VISIBLE WHEN THE PUSHER WAS FULLY SEATED IN THE INSTANT DETACHER CAP. THE IMPLANT COIL WAS SUCCESSFULLY DETACHED ON THE FIRST ATTEMPT WITHOUT ANY DIFFICULTY. ¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿UNABLE TO DETACH¿ REPORT COULD NOT BE CONFIRMED, AND THE CAUSE COULD NOT BE DETERMINED. NO DEFECT WAS FOUND WITH THE RETURNED INSTANT DETACHER. THE RETURNED INSTANT DETACHER WAS USED TO DETACH AN IN-HOUSE AXIUM COIL SUCCESSFULLY. THE AXIUM COIL USED IN THE EVENT WAS NOT RETURNED; THEREFORE, AN ANALYSIS COULD NOT BE PERFORMED AND CONFORMANCE TO SPECIFICATION COULD NOT BE ASSESSED. (ROSAJ10 2022-05-03) MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL COULD NOT BE DETACHED WITH AN INSTANT DETACHER. WHEN AN ATTEMPT WAS MADE TO DETACH THE AXIUM FROM THE PRODUCT, IT COULD NOT BE DETACHED. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95515 LRS INSTANT DETACHER DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICRO THERAPEUTICS, INC. DBA EV3 ID-1-5 B312101

    Patients

    Seq Age Sex Outcome Treatment
    1 Female