BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSPHERE 10 CERE, 5MMX9.7CM

    MDR report key: 8246071 · Received January 14, 2019

    Report

    Report Number
    3008114965-2019-00877
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    September 12, 2018
    Report Date
    October 16, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    HCG
    UDI-DI
    00878528001058
    PMA / PMN Number
    K0022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). BASED ON THE PRODUCT ANALYSIS COMPLETED ON 11-JAN-2019, THE EVENT NOW MEETS THE REQUIRED CRITERIA FOR MDR REPORTING AS A "MALFUNCTION". INFORMATION REGARDING PATIENT AGE/DATE OF BIRTH, GENDER, WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT PROVIDED. PROCODE: KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) THE PRODUCT LOT NUMBER WAS NOT REPORTED. INITIAL REPORTER - THE CUSTOMER CONTACT INFORMATION, INCLUDING PHONE, FAX, AND E-MAIL ADDRESS, WAS NOT REPORTED. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN DID NOT LIKE THE SHAPE OF COIL DEPLOYMENT OF THE 1.5MM X 2CM DELTAPAQ (CDF10015230/UNK LOT), 1.5MM X 3CM DELTAPLUSH 10 (CPL10015330/UNK LOT), AND THE 5MM X 9.7CM MICRUSPHERE 10 (CSP10050030/UNK LOT) AND DECIDED TO REMOVE THE COILS FROM THE PATIENT; HOWEVER, WHILE RESHEATHING THE COILS, THE INTRODUCERS FAILED TO BE REZIPPED. THE COIL WAS REPLACED WITH A SAME-LIKE COIL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN ADDITIONAL INFORMATION. THE 5MM X 9.7CM MICRUSPHERE 10 WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH THE EMBOLIC COIL IN THE GREEN INTRODUCER. THE EMBOLIC COIL WAS SEEN POSITIONED IN A WAVE AS OPPOSED TO STRAIGHT AND IN-LINE WITH THE INTRODUCER. THE EMBOLIC COIL WAS SEEN PROTRUDING FROM THE TRANSLUCENT INTRODUCER. THE LENGTH OF THE COIL WAS APPROXIMATELY 9.7 CM, WHICH CORRESPONDS WITH THE LENGTH OF THE COIL IN THE PRODUCT DESCRIPTION. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. THE EMBOLIC COIL WAS SEEN KINKED AT THE POINT OF PROTRUSION FROM THE INTRODUCER SKIVE. THE PROXIMAL END OF THE EMBOLIC COIL OUTSIDE OF THE INTRODUCER WAS SEEN STRETCHED. THE ARTICULATING JOINT WAS SEEN INTACT. THE DISTAL OUTER SHEATH HAD NOT SOFTENED, INDICATING THAT THE DETACHMENT PROCESS HAD NOT BEEN INITIATED. THERE WERE BLOOD MARKINGS ALONG THE INSIDE OF THE INTRODUCER IN THE PATTERN OF THE COIL. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. THE STERILE LOT NUMBER WAS NOT REPORTED; THEREFORE, A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. THE CUSTOMER REPORT OF POSITIONING DIFFICULTY COULD NOT BE EVALUATED SINCE POSITIONING DIFFICULTY IS SPECIFIC TO BOTH PROCEDURE AND SITUATION AND CANNOT BE REPRODUCED OR TESTED IN THE FAILURE ANALYSIS LAB. HOWEVER, THE OBSERVED DAMAGE TO THE EMBOLIC COIL MAY MAKE IT MORE DIFFICULT TO ACHIEVE CORRECT POSITIONING. WHILE THE SEQUENCE OF EVENTS LEADING TO THE OBSERVED DAMAGE TO THE COIL CANNOT BE DETERMINED BASED ON THE CONDITION OF THE RETURNED DEVICE, DAMAGE TO THE EMBOLIC COIL TYPICALLY OCCURS WHEN AN EXCESSIVE RETRACTION FORCE IS APPLIED IN THE PRESENCE OF RESISTANCE. THE PRESENCE OF BLOOD IN THE INTRODUCER SUGGESTS THAT AN INSUFFICIENT FLUSH WAS MAINTAINED. THE INSTRUCTIONS FOR USE (IFU) STATES THAT A CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND ALSO INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. IT IS POSSIBLE THAT THE DEVICE WAS MISHANDLED DURING RESISTANCE, CAUSING THE COIL TO PROTRUDE. THE CUSTOMER REPORT OF REZIPPING DIFFICULTY WAS CONFIRMED. THE EMBOLIC COIL AND DPU CORE WIRE PROTRUDED FROM THE INTRODUCER SKIVE DURING FUNCTIONAL TESTING. ZIPPING FUNCTIONALITY IS VERIFIED IN-PROCESS ON ALL DEVICES. IN ADDITION, 100% OF EMBOLIC COILS ARE INSPECTED IN-PROCESS FOR DAMAGE. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THESE ISSUES. THE DEVICE DOES NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE EVENT AS REPORTED. REZIPPING DIFFICULTY AND POSITIONING DIFFICULTY ARE KNOWN POTENTIAL ISSUES ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS SEVERAL CAUTIONS RELATING TO THESE SITUATIONS, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATIONS SHOULD THEY BE ENCOUNTERED DURING USE. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE MINIMAL INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL/HANDLING FACTORS, INCLUDING VESSEL/ANEURYSM CHARACTERISTICS, DEVICE MANIPULATION, AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES NOTED TO THE RETURNED SYSTEM. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2019-00876 & 3008114965-2019-00877.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN DID NOT LIKE THE SHAPE OF COIL DEPLOYMENT OF THE 1.5MM X 2CM DELTAPAQ (CDF10015230/UNK LOT), 1.5MM X 3CM DELTAPLUSH 10 (CPL10015330/UNK LOT), AND THE 5MM X 9.7CM MICRUSPHERE 10 (CSP10050030/UNK LOT) AND DECIDED TO REMOVE THE COILS FROM THE PATIENT; HOWEVER, WHILE RESHEATHING THE COILS, THE INTRODUCERS FAILED TO BE REZIPPED. THE COIL WAS REPLACED WITH A SAME-LIKE COIL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. EVALUATION OF THE RETURNED MICRUSPHERE REVEALED KINKING AND STRETCHING OF THE EMBOLIC COIL. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39064 MSPHERE 10 CERE, 5MMX9.7CM NEUROVASCULAR EMBOLIZATION DEVICE HCG REFER TO SECTION H10 00878528001058

    Patients

    Seq Age Sex Outcome Treatment
    1