BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAXSFT10 1.5MM X 2CM

    MDR report key: 11943475 · Received June 4, 2021

    Report

    Report Number
    3008114965-2021-00240
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    January 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077251
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN ATTEMPTED TO RESHEATH THE 1.5MM X 2CM DELTAXSFT 10 COIL (DLX100152 / K10016) AFTER DECIDING THAT THE COIL WAS NOT THE PROPER CHOICE TO BE USED FOR THE PROCEDURE. HOWEVER, THE RESHEATHING ATTEMPT FAILED BECAUSE THE INTRODUCER SHEATH SPLIT. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT HAVING TO REMOVE THE MICROCATHETER. IT WAS CONFIRMED THAT ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AND THERE WAS NO RESISTANCE ENCOUNTERED WHEN THE COIL WAS BEING ADVANCED THROUGH THE MICROCATHETER. THERE WAS NO PROCEDURE DELAY AS A RESULT OF THE REPORTED EVENT; THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE COMPLAINT COIL WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 1.5MM X 2CM DELTAXSFT 10 COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE DEVICE POSITIONING UNIT (DPU) WAS OBSERVED PROTRUDING FROM THE INTRODUCER. THE RESHEATHING TOOL WAS BROKEN INTO TWO. NO ADDITIONAL DAMAGES NOR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. MICROSCOPIC INSPECTION WAS PERFORMED. THE INTRODUCER WAS OBSERVED WITH A KINKED / BENT SECTION. THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE RESHEATHING TOOL BEING BROKEN IN TWO PIECES. THE DPU WAS PROTRUDING FROM THE INTRODUCER AND THE INTRODUCER WAS KINKED / BENT. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10016) 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 CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE ISSUE REPORTED IN THE COMPLAINT IS RELATED TO THE FAILED ATTEMPT TO RESHEATH THE COIL AFTER THE PHYSICIAN DECIDED THAT IT WAS NOT THE CORRECT COIL TO BE USED FOR THE PROCEDURE. THE INTRODUCER SHEATH WAS REPORTED SPLIT. THE COMPLAINT DEVICE WAS RETURNED. OBSERVATION DURING THE VISUAL INSPECTION NOTED THAT THE RESHEATHING TOOL IS BROKEN IN TWO, THE INTRODUCER SHEATH WAS KINKED / BENT WITH THE DPU PROTRUDING FROM IT. THESE OBSERVATIONS CONFIRMED THE REPORTED ISSUE, THOUGH THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. IN ADDITION, DURING THE MICROSCOPIC INSPECTION, THE EMBOLIC COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. THE CONDITION OF THE COIL WAS NOT ORIGINALLY REPORTED IN THE COMPLAINT. 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. THE CONDITION OF THE COIL APPEARS TO BE DUE TO INADVERTENT FORCE APPLIED TO THE DEVICE DURING PROCEDURE HANDLING, THOUGH THIS CANNOT BE CONCLUSIVELY DETERMINED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. IN ADDITION, DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT THE 1.5MM X 2CM DELTAXSFT 10 COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL IN THE STRETCHED CONDITION AS OBSERVED DURING THE MICROSCOPIC INSPECTION. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING CAUTIONS: DO NOT FASTEN THE ROTATING HEMOSTASIS VALVE (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 CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RE-SHEATHING 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 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 THE PHYSICIAN ATTEMPTED TO RESHEATH THE 1.5MM X 2CM DELTAXSFT 10 COIL (DLX100152 / K10016) AFTER DECIDING THAT THE COIL WAS NOT THE PROPER CHOICE TO BE USED FOR THE PROCEDURE. HOWEVER, THE RESHEATHING ATTEMPT FAILED BECAUSE THE INTRODUCER SHEATH SPLIT. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT HAVING TO REMOVE THE MICROCATHETER. IT WAS CONFIRMED THAT ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AND THERE WAS NO RESISTANCE ENCOUNTERED WHEN THE COIL WAS BEING ADVANCED THROUGH THE MICROCATHETER. THERE WAS NO PROCEDURE DELAY AS A RESULT OF THE REPORTED EVENT; THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL AND MICROSCOPIC INSPECTIONS OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 04 JUNE 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838400 DELTAXSFT10 1.5MM X 2CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL DLX100152 K10016 10886704077251

    Patients

    Seq Age Sex Outcome Treatment
    1