BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 8MM X 35CM

    MDR report key: 10341441 · Received July 29, 2020

    Report

    Report Number
    3008114965-2020-00285
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 10, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077220
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED BY THE LAB ON 08/03/2020; THE RETURNED PRODUCT UNDERWENT EVALUATION AND ANALYSIS. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION WITH THE TARGET AT THE INFERIOR MESENTERIC ARTERY (IMA), THE CONCOMITANT MICROCATHETER WAS ADVANCED TOWARD THE LESION, THE PHYSICIAN THEN ATTEMPTED TO USE THE 8MM X 35CM DELTAFILL 18 COIL (DLF180835 / K10117), BUT THE COMPLAINT COIL WAS BROKEN AND THE COIL BECAME PROTRUDED FROM THE DISTAL END OF THE SHEATH EVEN THOUGH THE PHYSICIAN DID NOT PUSH IT. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND THE REPLACEMENT COIL WAS IMPLANTED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE REPORTED EVENT DID NOT RESULT ANY PROCEDURAL DELAY OR PROLONGATION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 8MM X 35CM DELTAFILL 18 COIL WAS RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE INTRODUCER WAS PARTIALLY ZIPPED AND KINKED; THE DEVICE POSITIONING UNIT (DPU) WAS KINKED NEAR THE HUB. A MICROSCOPIC INSPECTION WAS PERFORMED. THE MARKER BAND WAS FOUND 70CM FROM THE DISTAL END; THIS IS WITHIN SPECIFICATION. THE EMBOLIC COIL WAS OBSERVED KINKED AND PROTRUDING FROM THE INTRODUCER. NO OTHER DAMAGE WAS OBSERVED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10117) 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. THE COMPLAINT DOCUMENTED THAT DURING THE EMBOLIZATION PROCEDURE WITH THE TARGET AT THE IMA, THE MICROCATHETER WAS ADVANCED TOWARD THE TARGET LESION AND THE PHYSICIAN ATTEMPTED TO USE THE 8MM X 35CM DELTAFILL 18 COIL, BUT THE COIL WAS BROKEN AND BECAME PROTRUDED FROM THE DISTAL END OF THE SHEATH. THE COIL INTRODUCER WAS OBSERVED PARTIALLY ZIPPED AND IN KINKED CONDITION. THE PRESCORE RUPTURE IS CONFIRMED, WITH THE KINKED CONDITION OF THE COIL INTRODUCER, THE INTRODUCER WILL NOT BE FULLY REZIPPED, THE PARTIALLY ZIPPED CONDITION OF THE INTRODUCER CONFIRMED IT. THE COIL WAS OBSERVED KINKED AND PROTRUDING FROM THE INTRODUCER, THE KINKED CONDITION OF THE COIL IS LIKELY THE REPORTED ¿BROKEN¿ CONDITION OF THE COIL DOCUMENTED IN THE COMPLAINT. COIL KINKING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTION FOR USE PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT ISSUES SUCH AS KINK FROM OCCURRING. THE EXACT CAUSE OF THE REPORTED ISSUE RELATED TO THE CONDITION OF THE COIL BEING DAMAGED / KINKED CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, THE EMBOLIC COIL WAS OBSERVED PROTRUDING FROM THE COIL INTRODUCER THAT WAS PARTIALLY ZIPPED AND ALSO KINKED INDICATE THAT FORCE MAY BE THE MOST LIKELY CONTRIBUTING FACTOR. FORCE MAY HAVE BEEN INADVERTENTLY APPLIED DURING PROCEDURAL DEVICE HANDLING WHEN THE COIL WAS BEING ADVANCED TOWARD THE TARGET LESION WHICH RESULTED IN BOTH THE EMBOLIC COIL AND THE INTRODUCER TO KINK. BASED ON THE REVIEW OF THE MANUFACTURING DOCUMENTATION, 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 DEVICE. THUS, IT IS NOT LIKELY THAT THE 8MM X 35CM DELTAFILL 18 COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL AND THE DPU IN THE OBSERVED KINKED CONDITION, AND WITH THE COIL INTRODUCER PARTIALLY ZIPPED, KINKED WITH THE EMBOLIC COIL PROTRUDING FROM IT. 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.

    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. 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. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10117) 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. 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 COIL EMBOLIZATION WITH THE TARGET AT THE INFERIOR MESENTERIC ARTERY (IMA), THE CONCOMITANT MICROCATHETER WAS ADVANCED TOWARD THE LESION, THE PHYSICIAN THEN ATTEMPTED TO USE THE 8MM X 35CM DELTAFILL 18 COIL (DLF180835 / K10117), BUT THE COMPLAINT COIL WAS BROKEN AND THE COIL BECAME PROTRUDED FROM THE DISTAL END OF THE SHEATH EVEN THOUGH THE PHYSICIAN DID NOT PUSH IT. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND THE REPLACEMENT COIL WAS IMPLANTED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE REPORTED EVENT DID NOT RESULT ANY PROCEDURAL DELAY OR PROLONGATION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804679 DELTAFILL18 8MM X 35CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL DLF180835 K10117 10886704077220

    Patients

    Seq Age Sex Outcome Treatment
    1