BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 CERE 5MMX17CM

    MDR report key: 13098589 · Received December 28, 2021

    Report

    Report Number
    3008114965-2021-00781
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 28, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    00878528003014
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT REPORTED / AVAILABLE. INITIAL REPORTER FACILITY NAME: (B)(6). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED INTERNAL CAROTID ARTERY (ICA) ANEURYSM EMBOLIZATION PROCEDURE, WITH THE (B)(6) FEMALE PATIENT UNDER GENERAL ANESTHESIA, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE COMPLAINT COIL, A 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730 / K10429) IN THE MICROCATHETER, BUT IT THE COIL BECAME IMPEDED IN THE HUB SECTION OF THE MICROCATHETER (UNSPECIFIED BRAND). IT WAS REPORTED THAT FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AND THE COMPLAINT DEVICE WAS NOT SUBJECTED TO EXCESSIVE FORCE. THE PHYSICIAN RETRACTED THE COIL; IT WAS NOT USED IN THE PATIENT AND IT DID NOT GO THROUGH THE MICROCATHETER. A NEW COIL WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 5MM X 17CM PRESIDIO 10 CERECYTE COIL WAS RECEIVED. VISUAL INSPECTION WAS PERFORMED. THE INTRODUCER IS OBSERVED SPLIT CAUSING THE EMBOLIC COIL TO PROTRUDE FROM IT. NO OTHER DAMAGES NOR ANOMALIES WERE NOTED DURING THE VISUAL INSPECTION. MICROSCOPIC INSPECTION WAS PERFORMED. UNDER MAGNIFICATION, THE EMBOLIC COIL IS OBSERVED PROTRUDING FROM THE INTRODUCER IN STRETCHED CONDITION. FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE EMBOLIC COIL BEING STRETCHED AND PROTRUDING FROM THE INTRODUCER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10429) 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. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE COMPLAINT DOCUMENTED THAT WHEN THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE COMPLAINT COIL IN THE MICROCATHETER, IT BECAME IMPEDED IN THE HUB SECTION. THE PHYSICIAN RETRACTED THE COIL AND EXCHANGED IT FOR A NEW DEVICE. THE DEVICE WAS RETURNED AND DURING VISUAL INSPECTION, THE INTRODUCER WAS NOTED TO BE SPLIT AND THE EMBOLIC COIL WAS OBSERVED PROTRUDING FROM THE INTRODUCER. MICROSCOPIC INSPECTION FURTHER REVEALED THAT THE EMBOLIC COIL IS ALSO IN STRETCHED CONDITION. THE CONDITION OF THE RETURNED COMPLAINT DEVICE MAY HAVE OCCURRED DURING THE ATTEMPT TO RETRACT THE COIL WHEN IT BECAME IMPEDED IN THE MICROCATHETER HUB. THOUGH IT WAS REPORTED THAT THE DEVICE WAS NOT SUBJECTED TO EXCESSIVE FORCE, IT MAY HAVE BEEN SUBJECTED TO INADVERTENT FORCE WHICH CAUSE THE COIL INTRODUCER TO SPLIT, THE EMBOLIC COIL TO PROTRUDE FROM THE INTRODUCER AND THEN BECAME STRETCHED AS NOTED DURING THE MICROSCOPIC INSPECTION. BASED ON THE VISUAL AND MICROSCOPIC INSPECTIONS, THE REPORTED ISSUE WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT FASTEN THE RHV VALVE TOO TIGHTLY AROUND THE INTRODUCER SHEATH SINCE EXCESSIVE PRESSURE MAY CAUSE DAMAGE TO THE INTRODUCER SHEATH AND/OR THE MICROCOIL AS IT IS ADVANCED INTO THE INFUSION MICROCATHETER. ADDITIONALLY, IF THE INTRODUCER TIP AND MICROCATHETER HUB ARE MISALIGNED, DAMAGE MAY OCCUR TO THE MICROCOIL AS IT PASSES THROUGH THIS TRANSITION. IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY THE LOCKING MECHANISM, OR CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RESHEATHING TOOL APPROXIMATELY 1 IN (2-3 CM). IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM THROUGH THE INTRODUCER, OPEN THE RHV MAIN VALVE, AND PARTIALLY WITHDRAW THE DISTAL END OF THE INTRODUCER TO EXPOSE ITS TIP WITHIN THE RHV. TIGHTEN THE RHV MAIN VALVE AND FLUSH THE Y-CONNECTOR OF THE RHV WITH STERILE SALINE AND VERIFY THAT FLUID EXITS THE SLIT IN THE CLEAR PORTION OF THE INTRODUCER. AFTER FLUSHING, REINSERT THE INTRODUCER INTO THE INFUSION CATHETER HUB AS DESCRIBED IN ¿MICROCOIL PLACEMENT¿ SECTION ABOVE. IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICROCOIL SYSTEM AND EXAMINE FOR DAMAGE. REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS, WITHDRAW, AND EXAMINE THE DELIVERY CATHETER SYSTEM. COIL STRETCHING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUE FROM OCCURRING. STRETCHING CAN OCCUR DURING PROCEDURE HANDLING WHERE FORCE MAY HAVE BEEN INADVERTENTLY APPLIED. THE STRETCHED CONDITION OF THE EMBOLIC COIL WAS NOT ORIGINALLY REPORTED IN THE COMPLAINT. THE EXACT CAUSE OF THE STRETCHED CONDITION OF THE COIL CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT WHEN THE COIL WAS IMPEDED IN THE MICROCATHETER HUB, SOME FORCE WAS EXERTED IN ATTEMPT TO PUSH IT THROUGH AND WHEN THE EFFORT WAS NOT SUCCESSFUL, THE COIL WAS RETRACTED AND REPLACED. DURING THE ATTEMPT TO RETRACT THE COIL, IT MAY HAVE BEEN SUBJECTED TO SOME UNDUE FORCE RESULTING IT BECOMING STRETCHED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT 5MM X 17CM PRESIDIO 10 CERECYTE COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN STRETCHED CONDITION. 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 INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED INTERNAL CAROTID ARTERY (ICA) ANEURYSM EMBOLIZATION PROCEDURE, WITH THE (B)(6) FEMALE PATIENT UNDER GENERAL ANESTHESIA, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE COMPLAINT COIL, A 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730 / K10429) IN THE MICROCATHETER, BUT IT THE COIL BECAME IMPEDED IN THE HUB SECTION OF THE MICROCATHETER (UNSPECIFIED BRAND). IT WAS REPORTED THAT FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AND THE COMPLAINT DEVICE WAS NOT SUBJECTED TO EXCESSIVE FORCE. THE PHYSICIAN RETRACTED THE COIL; IT WAS NOT USED IN THE PATIENT AND IT DID NOT GO THROUGH THE MICROCATHETER. A NEW COIL WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL, THE EMBOLIC COIL WAS OBSERVED PROTRUDING FROM THE INTRODUCER AND IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 28 DEC 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994953 PRESIDIO 10 CERE 5MMX17CM NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL PC4100517-30 K10429 00878528003014

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female