BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 10MM X 40CM

    MDR report key: 10516518 · Received September 10, 2020

    Report

    Report Number
    3008114965-2020-00413
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    July 29, 2020
    Report Date
    July 29, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077114
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS IS NOT AVAILABLE / REPORTED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT-GRAFT COIL EMBOLIZATION PROCEDURE, THE SHEATH INTRODUCER OF THE 10MM X 40CM DELTAFILL 18 COIL (DLF181040 / K10232) WAS PRESSED AGAINST THE HUB OF THE CONCOMITANT MICROCATHETER THAT WAS BEING USED FOR COILING SUPPORT, THE COIL WAS INSERTED INTO THE MICROCATHETER BUT PART OF THE SHEATH GOT SPLIT AND THE COIL WAS EXPOSED FROM THE SPLIT PART OF THE SHEATH. ANOTHER 10MM X 40CM DELTAFILL 18 COIL FROM LOT K10147 WAS CHOSEN AS A REPLACEMENT BUT THE SAME ISSUE WITH THE SPLIT SHEATH OCCURRED. A THIRD COIL WAS CHOSEN, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 10MM X 40CM DELTAFILL 18 COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE COIL WAS OBSERVED PROTRUDING FROM THE COIL INTRODUCER AT 171CM FROM THE CONNECTOR. SEVERAL KINKS WERE OBSERVED ON THE DEVICE POSITIONING UNIT (DPU). THE MARKER BAND WAS FOUND AT 75 CM FROM THE DISTAL END; THIS IS WITHIN SPECIFICATION. UNDER MICROSCOPIC INSPECTION, UNDER MAGNIFICATION, THE EMBOLIC COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. NO OTHER DAMAGE WAS NOTED. THE CUSTOMER REPORTED ISSUE THAT THE SHEATH WAS SPLIT, AND THE COIL BECAME PROTRUDED FROM THE SPLIT PART OF THE SHEATH INTRODUCER. THIS ISSUE WAS CONFIRMED. THE RETURNED DEVICE UNDERWENT VISUAL AND MICROSCOPIC INSPECTIONS; THE COIL WAS OBSERVED PROTRUDING FROM THE SHEATH OF THE COIL INTRODUCER. THE EMBOLIC COIL WAS IN A STRETCHED CONDITION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10232) 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. COIL STRETCHING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE IFU PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUE FROM OCCURRING. STRETCHING CAN OCCUR DURING ATTEMPTS TO WITHDRAWAL THE COIL AGAINST RESISTANCE. THE ISSUE THAT WAS REPORTED WITH THE USE OF THE 10MM X 40CM DELTAFILL 18 COIL WAS PRESSED AGAINST THE HUB OF THE MICROCATHETER WHEN THE COIL WAS BEING INSERTED INTO THE MICROCATHETER; THE COIL INTRODUCER SHEATH BECAME SPLIT AND THE COIL PROTRUDED FROM THE SPLIT PART OF THE SHEATH. THE STRETCHED COIL CONDITION WAS NOT ORIGINALLY REPORTED IN THE COMPLAINT. IT IS POSSIBLE THAT WHEN THE COIL WAS PRESSED AGAINST THE MICROCATHETER HUB DURING INSERTION INTO THE MICROCATHETER, FORCE WAS APPLIED AND AS A RESULT, THE COIL STRETCHED AND PROTRUDED FROM THE SPLIT INTRODUCER. THE EXACT CAUSE OF THE COIL BECOMING STRETCHED 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 10MM X 40CM DELTAFILL 18 COIL LEFT THE MANUFACTURING FACILITY WITH THE COIL IN THE OBSERVED 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 · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT-GRAFT COIL EMBOLIZATION PROCEDURE, THE SHEATH INTRODUCER OF THE 10MM X 40CM DELTAFILL 18 COIL (DLF181040 / K10232) WAS PRESSED AGAINST THE HUB OF THE CONCOMITANT MICROCATHETER THAT WAS BEING USED FOR COILING SUPPORT, THE COIL WAS INSERTED INTO THE MICROCATHETER BUT PART OF THE SHEATH GOT SPLIT AND THE COIL WAS EXPOSED FROM THE SPLIT PART OF THE SHEATH. ANOTHER 10MM X 40CM DELTAFILL 18 COIL FROM LOT K10147 WAS CHOSEN AS A REPLACEMENT BUT THE SAME ISSUE WITH THE SPLIT SHEATH OCCURRED. A THIRD COIL WAS CHOSEN, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE (DLF181040 / K10232) WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS 9/8/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980890 DELTAFILL18 10MM X 40CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL DLF181040 K10232 10886704077114

    Patients

    Seq Age Sex Outcome Treatment
    1