BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 8728121 · Received June 24, 2019

    Report

    Report Number
    3014162263-2019-00009
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    April 24, 2019
    Report Date
    June 27, 2019
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    PMA / PMN Number
    K172390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TO WHOM IT MAY CONCERN: ON JUNE 14, 2019, BALT USA RECEIVED A COMPLAINT REGARDING THE USE OF A SINGLE OPTIMA COIL (OPTIMA COMPLEX 10 SOFT). DETAILS REPORTED AS FOLLOWS: "APPEARANCE OF GRANULOMAS ON MRI FOLLOWING EMBOLIZATION OF AN INTRACRANIAL ANEURYSM IN THE ACUTE HAEMORRHAGIC PHASE PATIENT INFORMATION: CURRENT STATUS OF THE PATIENT: TRANSIENT SENSORY DISORDER OF THE UPPER LEFT ACTIONS TAKEN IN THE CARE FACILITY FOR THE CARE OF THE PATIENT: INTRODUCTION OF A CORTICOSTEROID (ORAL)." THE RESULTS OF OUR INVESTIGATION FOLLOWING RETURN OF THE AFFECTED DEVICE, ARE SUMMARIZED AS FOLLOWS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED DEVICE WAS REPORTED UNAVAILABLE. 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 FOR THE REPORTED LOTS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINT AGAINST LOT NUMBER 053018D HAS BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND. NORMAL PROCESSING FOR STERILIZATION WAS ACHIEVED WITH PASSING RESULTS WITHIN SPECIFICATION. VENDOR CERTIFIES LOT 053018D RECEIVED THE INDICATED DOSES WITHIN THE PRECISION AND ACCURACY OF THE DOSIMETRY SYSTEM EMPLOYED. POST-OPERATION INFECTION IS A KNOWN RISK FOR NEUROVASCULAR COILING AND CAN BE CAUSED BY MANY REASONS, SUCH AS THE PATIENT BEING PRONE TO INFECTION, OTHER DEVICES CAUSING THE INFECTION, OR ANY CONTACT THE IMPLANT MIGHT HAVE HAD ONCE THE POUCH WAS OPENED. 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: "APPEARANCE OF GRANULOMAS ON MRI FOLLOWING EMBOLIZATION OF AN INTRACRANIAL ANEURYSM IN THE ACUTE HAEMORRHAGIC PHASE. PATIENT INFORMATION: CURRENT STATUS OF THE PATIENT: TRANSIENT SENSORY DISORDER OF THE UPPER LEFT ACTIONS TAKEN IN THE CARE FACILITY FOR THE CARE OF THE PATIENT: INTRODUCTION OF A CORTICOSTEROID (ORAL)."

    Additional Manufacturer Narrative · 1

    TO WHOM IT MAY CONCERN: ON JUNE 14, 2019, BALT USA RECEIVED A COMPLAINT REGARDING THE USE OF A SINGLE OPTIMA COIL (OPTIMA COMPLEX 10 SOFT). DETAILS REPORTED AS FOLLOWS: "APPEARANCE OF GRANULOMAS ON MRI FOLLOWING EMBOLIZATION OF AN INTRACRANIAL ANEURYSM IN THE ACUTE HAEMORRHAGIC PHASE. PATIENT INFORMATION: CURRENT STATUS OF THE PATIENT: TRANSIENT SENSORY DISORDER OF THE UPPER LEFT ACTIONS TAKEN IN THE CARE FACILITY FOR THE CARE OF THE PATIENT: INTRODUCTION OF A CORTICOSTEROID (ORAL)." THE RESULTS OF OUR INVESTIGATION FOLLOWING RETURN OF THE AFFECTED DEVICE, ARE SUMMARIZED AS FOLLOWS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED DEVICE WAS REPORTED UNAVAILABLE. 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 FOR THE REPORTED LOTS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINT AGAINST LOT NUMBER 053018D HAS BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND. NORMAL PROCESSING FOR STERILIZATION WAS ACHIEVED WITH PASSING RESULTS WITHIN SPECIFICATION. VENDOR CERTIFIES LOT 053018D RECEIVED THE INDICATED DOSES WITHIN THE PRECISION AND ACCURACY OF THE DOSIMETRY SYSTEM EMPLOYED. POST-OPERATION INFECTION IS A KNOWN RISK FOR NEUROVASCULAR COILING AND CAN BE CAUSED BY MANY REASONS, SUCH AS THE PATIENT BEING PRONE TO INFECTION, OTHER DEVICES CAUSING THE INFECTION, OR ANY CONTACT THE IMPLANT MIGHT HAVE HAD ONCE THE POUCH WAS OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "APPEARANCE OF GRANULOMAS ON MRI FOLLOWING EMBOLIZATION OF AN INTRACRANIAL ANEURYSM IN THE ACUTE HAEMORRHAGIC PHASE. PATIENT INFORMATION: CURRENT STATUS OF THE PATIENT: TRANSIENT SENSORY DISORDER OF THE UPPER LEFT ACTIONS TAKEN IN THE CARE FACILITY FOR THE CARE OF THE PATIENT: INTRODUCTION OF A CORTICOSTEROID (ORAL)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521560 OPTIMA COIL SYSTEM OPTIMA COIL HCG BALT USA, LLC OPTI0208CSF10 053018D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention