BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSPHERE XL 6MMX20CM

    MDR report key: 10880756 · Received November 20, 2020

    Report

    Report Number
    3008114965-2020-00536
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 16, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    00878528009955
    PMA / PMN Number
    K032872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THE PUSHER WIRE OF THE 6MM X 20CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL (SSR10062020 / K10209) WOULD NOT ADVANCE THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) INTO THE HUB OF THE CONCOMITANT MICROCATHETER (BRAND UNKNOWN). THE INTRODUCER SHEATH WAS INSERTED INTO THE HUB OF THE MICROCATHETER CORRECTLY. AS THE PHYSICIAN WAS PUSHING THE COIL FORWARD, THE WIRE HERNIATED THROUGH THE INTRODUCER SHEATH. THE COIL WAS REMOVED FROM THE RHV AND ANOTHER COIL OF DIFFERENT SIZE AND TYPE WAS USED WITHOUT ANY SIGNIFICANT DIFFICULTY. THE POSITION OF THE MICROCATHETER REMAINED INSIDE THE ANEURYSM. THE SAME MICROCATHETER WAS USED DURING THE ENTIRE CASE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT OUTCOME AND THERE WAS NO SIGNIFICANT DELAY IN THE ANEURYSM TREATMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE RESISTANCE WAS NOT KNOWN. THE COMPLAINT DEVICE DID NOT APPEAR TO HAVE DAMAGE WHEN IT WAS REMOVED FROM THE PACKAGE. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. PRIOR TO THE ISSUE ENCOUNTERED WITH THE COMPLAINT COIL, TWO OTHER COILS (A 6MMX12CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL AND A 6MM X 15CM CASHMERE 14 STRETCH RESISTANT COIL) WERE SUCCESSFULLY USED WITH THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE INTRODUCER WAS NOT FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING THE COIL ADVANCEMENT. EXCESSIVE FORCE WAS NOT APPLIED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 6MM X 20CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL WAS RETURNED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE DEVICE POSITIONING UNIT (DPU) WAS OBSERVED WITH SEVERAL KINKED AREAS AND PROTRUDING FROM THE INTRODUCER. NO DAMAGE WAS OBSERVED ON THE INTRODUCER. THE RETURNED DEVICE UNDERWENT A MICROSCOPIC INSPECTION. THE EMBOLIC COIL WAS OBSERVED STRETCHED IN SEVERAL AREAS, BROKEN, AND PROTRUDING FROM THE INTRODUCER. NO OTHER DAMAGES WERE OBSERVED. FUNCTIONAL EVALUATION WAS PRECLUDED DUE TO THE CONDITION OF THE DEVICE. THE DPU WAS KINKED IN SEVERAL AREAS, PROTRUDING FROM THE INTRODUCER. THE EMBOLIC COIL WAS STRETCHED AND BROKEN. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10209) 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 PROCEDURE, THE PUSHER WIRE ON THE COMPLAINT COIL COULD NOT ADVANCE THROUGH THE RHV INTO THE HUB. AS THE PHYSICIAN PUSHED THE COIL FORWARD, THE WIRE HERNIATED THROUGH THE INTRODUCER SHEATH. THE ISSUE WAS CONFIRMED. BASED ON THE VISUAL AND MICROSCOPIC INSPECTION PERFORMED, THE DPU WAS KINKED IN SEVERAL AREAS AND WAS PROTRUDING FROM THE INTRODUCER. COILS CAN BECOME STRETCHED AND BROKEN DURING USE. THESE ARE KNOWN POTENTIAL ISSUES 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 AND BROKEN CONDITION OF THE EMBOLIC COIL WAS NOT ORIGINALLY REPORTED WITH THE COMPLAINT. THE EXACT CAUSE OF THE OBSERVED CONDITIONS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THEY MAY HAVE BEEN THE RESULTS OF INADVERTENTLY APPLIED FORCE WHEN THE PHYSICIAN WAS PUSHING THE COIL FORWARD. 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 6MM X 20CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL LEFT THE MANUFACTURING FACILITY WITH THE EMBOLIC COIL STRETCHED IN SEVERAL AREAS AND BROKEN. IT WAS ALSO INDICATED IN THE COMPLAINT THAT THE COMPLAINT DEVICE DID NOT APPEAR TO HAVE DAMAGE WHEN IT WAS REMOVED FROM THE PACKAGE. 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 STRETCHED CONDITION OBSERVED ON THE RETURNED COIL 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 PROCEDURE THE PUSHER WIRE OF THE 6MM X 20CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL (SSR10062020 / K10209) WOULD NOT ADVANCE THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) INTO THE HUB OF THE CONCOMITANT MICROCATHETER (BRAND UNKNOWN). THE INTRODUCER SHEATH WAS INSERTED INTO THE HUB OF THE MICROCATHETER CORRECTLY. AS THE PHYSICIAN WAS PUSHING THE COIL FORWARD, THE WIRE HERNIATED THROUGH THE INTRODUCER SHEATH. THE COIL WAS REMOVED FROM THE RHV AND ANOTHER COIL OF DIFFERENT SIZE AND TYPE WAS USED WITHOUT ANY SIGNIFICANT DIFFICULTY. THE POSITION OF THE MICROCATHETER REMAINED INSIDE THE ANEURYSM. THE SAME MICROCATHETER WAS USED DURING THE ENTIRE CASE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT OUTCOME AND THERE WAS NO SIGNIFICANT DELAY IN THE ANEURYSM TREATMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE RESISTANCE WAS NOT KNOWN. THE COMPLAINT DEVICE DID NOT APPEAR TO HAVE DAMAGE WHEN IT WAS REMOVED FROM THE PACKAGE. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. PRIOR TO THE ISSUE ENCOUNTERED WITH THE COMPLAINT COIL, TWO OTHER COILS (A 6MMX12CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL AND A 6MM X 15CM CASHMERE 14 STRETCH RESISTANT COIL) WERE SUCCESSFULLY USED WITH THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE INTRODUCER WAS NOT FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER, AND LOCKED WITH THE RHV DURING THE COIL ADVANCEMENT. EXCESSIVE FORCE WAS NOT APPLIED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION, THE EMBOLIC COIL WAS OBSERVED TO BE PROTRUDING FROM THE INTRODUCER IN STRETCHED AND BROKEN CONDITION. BASED ON THE PRODUCT ANALYSIS ON 11/20/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345688 MICRUSPHERE XL 6MMX20CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL SSR100620-20 K10209 00878528009955

    Patients

    Seq Age Sex Outcome Treatment
    1