BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSPHERE 10 PLAT 2.5MMX3.3CM

    MDR report key: 8144661 · Received December 7, 2018

    Report

    Report Number
    3008114965-2018-00817
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 20, 2018
    Report Date
    November 24, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    00878528003519
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM, THE PHYSICIAN USED THE MICRUSPHERE 10 PLATINUM 2.5MM X 3.3CM COIL (SPH10025020 / S11747), AND THE COIL STRETCHED. THE PHYSICIAN FOUND THAT THE COIL COULD NOT CHANGE ITS SHAPE TO BE A BASKET-LIKE; IT WAS ALSO NOT CONFORMING WELL TO THE ANEURYSM WALL WHICH INCREASES THE RISK OF SUBSEQUENT ANEURYSM EMBOLIZATION. THE PHYSICIAN DECIDED TO REMOVE THE MICRUSPHERE 10 PLATINUM COIL AND REPLACED IT WITH THE CASHMERE 14 CERECYTE 3MM X 4CM COIL (CRC14030430) WHICH SUCCESSFULLY FORMED THE BASKET-LIKE SHAPE THAT THE PREVIOUS COIL COULD NOT ACHIEVE. THE PHYSICIAN USED THE DELTAPAQ 10 CERECYTE 1.5MM X 2CM COIL (CDF10015230) TO FILL IN THE ANEURYSM COMPLETELY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT INJURY OR ADVERSE EVENT. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED AND HANDLED ACCORDING TO THE LABELING INSTRUCTIONS / INSTRUCTIONS FOR USE (IFU). THE DEVICE PACKAGING WAS SECURE. THERE WAS NO DAMAGE TO THE PACKAGING. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THE 2.5MM X 3.3CM MICRUSSPHERE 10 PLATINUM COIL WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE RETURNED MICRUSSPHERE 10 PLATINUM COIL WAS RECEIVED COILED AND CONTAINED IN A POUCH. THE DEVICE POSITIONING UNIT (DPU) WAS INSPECTED AND WAS OBSERVED TO BE WITHOUT ANY DAMAGE. THE COIL INTRODUCER WAS ZIPPED AND WAS ALSO WITHOUT DAMAGE. THE V-NOTCH OF THE RESHEATHING TOOL WAS ALSO OBSERVED TO HAVE NO DAMAGE. THE EXTENDED COIL, THE DPU, THE ARTICULATING JOINT, RESISTANCE HEATING AND THE EMBOLIC COIL WERE OBSERVED IN THE GREEN INTRODUCER. THE RETURNED DEVICE UNDERWENT MICROSCOPIC INSPECTION AND WAS CONFIRMED TO BE WITHOUT ANY DAMAGE. RESIDUES OF DRIED BLOOD WERE OBSERVED ON THE EMBOLIC COIL. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (S11747) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. BASED ON THE EVALUATION OF THE RETURNED .5MM X 3.3CM MICRUSSPHERE 10 PLATINUM COIL, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT THAT WHEN THE PHYSICIAN WAS TREATING AN INTRACRANIAL ANEURYSM AND THE MICRUSSPHERE COIL WAS NOT ABLE TO FORM THE BASKET-LIKE SHAPE AND WAS NOT CONFORMING TO THE ANEURYSM AND EVENTUALLY THE COIL BECAME STRETCHED COULD NOT BE CONFIRMED. THE EMBOLIC COIL OF THE RETURNED DEVICE OBSERVED TO BE WITHOUT ANY DAMAGE WITH THE ARTICULATING JOINT AND THE RESISTANCE HEATING ALSO DAMAGE-FREE. THE CAUSE OF THE REPORTED ISSUE IS NOT KNOWN AND CANNOT BE CONCLUSIVELY DETERMINED. IT WAS NOT CONFIRMED THROUGH THE EVALUATION OF THE RETURNED DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD ALSO DID NOT IDENTIFY ANY ISSUE OR 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 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 Manufacturer Narrative · 0

    MANUFACTURER¿S REF. (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED BY THE PRODUCT ANALYSIS LAB ON (B)(6) 2018. THE RETURN PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO DOCUMENT THE RESULT OF THE ANALYSIS OF THE PRODUCTION RECORDS FOR LOT S11747. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (S11747) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. 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. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). (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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM, THE PHYSICIAN USED THE MICROSPHERE 10 PLATINUM 2.5MM X 3.3CM COIL (SPH10025020 / S11747), AND THE COIL STRETCHED. THE PHYSICIAN FOUND THAT THE COIL COULD NOT CHANGE ITS SHAPE TO BE A BASKET-LIKE; IT WAS ALSO NOT CONFORMING WELL TO THE ANEURYSM WALL WHICH INCREASES THE RISK OF SUBSEQUENT ANEURYSM EMBOLIZATION. THE PHYSICIAN DECIDED TO REMOVE THE MICROSPHERE 10 PLATINUM COIL AND REPLACED IT WITH THE CASHMERE 14 CERECYTE 3MM X 4CM COIL ((B)(4)) WHICH SUCCESSFULLY FORMED THE BASKET-LIKE SHAPE THAT THE PREVIOUS COIL COULD NOT ACHIEVE. THE PHYSICIAN USED THE DELTAPAQ 10 CERECYTE 1.5MM X 2CM COIL ((B)(4)) TO FILL IN THE ANEURYSM COMPLETELY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT INJURY OR ADVERSE EVENT. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED AND HANDLED ACCORDING TO THE LABELING INSTRUCTIONS / INSTRUCTIONS FOR USE (IFU). THE DEVICE PACKAGING WAS SECURE. THERE WAS NO DAMAGE TO THE PACKAGING. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982160 MSPHERE 10 PLAT 2.5MMX3.3CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 S11747 00878528003519

    Patients

    Seq Age Sex Outcome Treatment
    1