BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 5MM X 20CM

    MDR report key: 15792121 · Received November 14, 2022

    Report

    Report Number
    3008114965-2022-00690
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 28, 2022
    Report Date
    December 12, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704076926
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. PROCODE IS KRD/HCG. INITIAL REPORTER: THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE 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 (K10632) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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 · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 21-NOV-2022. [ADDITIONAL INFORMATION]: ON 21-NOV-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT IT WAS A MARVEL® MICROCATHETER USED, BUT NO FURTHER INFORMATION COULD BE OBTAINED. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WERE NO KINKS ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. WHEN THE COIL WAS REMOVED, THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL ASIDE FROM THE REPORTED UNRAVELED CONDITION. THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED ISSUE. E.1: INITIAL REPORTER PHONE: (B)(6). 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 · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT WAS TARGETING A LESION ON THE INTERNAL THORACIC ARTERY, THE ¿PARENT¿ CATHETER WAS INSERTED AND DELIVERED TO THE ENTRANCE OF THE INTERNAL THORACIC ARTERY. THE MAIN VESSEL WAS EMBOLIZED WITH A MICROCATHETER, A MARVEL® MICROCATHETER (TOKAI MEDICAL PRODUCTS). THE PARENT CATHETER WAS ABLE TO APPROACH THE EMBOLIZED REGION AND THE MICROCATHETER WAS USED. THE CATHETER WAS FLUSHED AND THE COMPLAINT COIL, A 5MM X 20CM DELTAFILL 18 (DLF180520 / K10632) WAS USED AS THE FIRST COIL. ANCHORING WAS APPLIED AND THE COMPLAINT COIL WAS RE-SHEATHED TO BE SHAPED AS INTENDED. HOWEVER, THE COMPLAINT COIL WAS ¿UNABLE TO BE PUSHED AT ALL¿ EVEN THOUGH THE COMPLAINT COIL WAS RETRACTED, IT DID NOT SHOW IT RETRACTED ON IMAGE(S). THE PHYSICIAN JUDGED THE COMPLAINT COIL TO BE UNRAVELED. THE COMPLAINT COIL WAS RETRACTED TOGETHER WITH THE MICROCATHETER INTO THE PARENT CATHETER. THE COMPLAINT COIL AND THE MICROCATHETER WERE REPLACED WITH OTHER DEVICES AND THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS NOT MAINTAINED. ON 21-NOV-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT IT WAS A MARVEL® MICROCATHETER USED, BUT NO FURTHER INFORMATION COULD BE OBTAINED. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WERE NO KINKS ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. WHEN THE COIL WAS REMOVED, THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL ASIDE FROM THE REPORTED UNRAVELED CONDITION. THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 5MM X 20CM DELTAFILL 18 WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. IT WAS OBSERVED THAT THE COMPLAINT DEVICE REMAINS PARTIALLY INSIDE THE CONCOMITANT MARVEL MICROCATHETER. THE DISTAL PORTION OF THE COIL WAS NOTED TO BE IN SEVERELY STRETCHED CONDITION AND OUTSIDE OF THE TIP OF THE MARVEL MICROCATHETER. AN UNSUCCESSFUL ATTEMPT WAS MADE TO REMOVE THE COMPLAINT DEVICE FROM THE CONCOMITANT MICROCATHETER; STRONG RESISTANCE WAS ENCOUNTERED. THE MARVEL MICROCATHETER WAS DISSECTED TO INSPECT THE EMBOLIC COIL COMPONENT THAT IS INSIDE THE MICROCATHETER. IT WAS OBSERVED THAT THE COIL WAS SEVERELY STRETCHED AND REMAINED ATTACHED TO THE RESISTANCE HEATING (RH) COIL. THE INNER LUMEN OF THE MARVEL MICROCATHETER WAS OBSERVED TO BE SATURATED WITH RESIDUES OF DRIED BLOOD. 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 ISSUES FROM OCCURRING. STRETCHING CAN OCCUR DURING PROCEDURE HANDLING WHERE FORCE MAY HAVE BEEN INADVERTENTLY APPLIED. THIS CONDITION CONFIRMS THE END USER¿S ALLEGATION REGARDING A COIL STRETCHING. THE COMPLAINT INFORMATION INDICATES THAT CONTINUOUS FLUSH HAD NOT BEEN DONE; WITHOUT AN ADEQUATE FLUSH, ISSUES SUCH AS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER CAN ARISE, WHICH MAY CAUSE SOME FORCE TO BE INADVERTENTLY EXERTED ON THE DEVICE WHEN THE COIL WAS PUSHED AND THEN RETRACTED, WHICH CAN RESULT IN THE COIL BECOMING STRETCHED. BASED ON THIS, THE REPORTED ISSUE IN THE COMPLAINT REGARDING AN IMPEDED CONDITION WAS CONFIRMED. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10632) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT MULTIPLE FACTORS COULD CAUSE PRODUCT FAILURE. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATION: ¿ 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. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, H.6, AND H.10. 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 · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB 12-DEC-2022. THE RETURNED PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. 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 AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT WAS TARGETING A LESION ON THE INTERNAL THORACIC ARTERY, THE ¿PARENT¿ CATHETER WAS INSERTED AND DELIVERED TO THE ENTRANCE OF THE INTERNAL THORACIC ARTERY. THE MAIN VESSEL WAS EMBOLIZED WITH A MICROCATHETER, A MARVEL® MICROCATHETER (TOKAI MEDICAL PRODUCTS). THE PARENT CATHETER WAS ABLE TO APPROACH THE EMBOLIZED REGION AND THE MICROCATHETER WAS USED. THE CATHETER WAS FLUSHED AND THE COMPLAINT COIL, A 5MM X 20CM DELTAFILL 18 (DLF180520 / K10632) WAS USED AS THE FIRST COIL. ANCHORING WAS APPLIED AND THE COMPLAINT COIL WAS RE-SHEATHED TO BE SHAPED AS INTENDED. HOWEVER, THE COMPLAINT COIL WAS ¿UNABLE TO BE PUSHED AT ALL¿ EVEN THOUGH THE COMPLAINT COIL WAS RETRACTED, IT DID NOT SHOW IT RETRACTED ON THE IMAGE(S). THE PHYSICIAN JUDGED THE COMPLAINT COIL TO BE UNRAVELED. THE COMPLAINT COIL WAS RETRACTED TOGETHER WITH THE MICROCATHETER INTO THE PARENT CATHETER. THE COMPLAINT COIL AND THE MICROCATHETER WERE REPLACED WITH OTHER DEVICES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS NOT MAINTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830428 DELTAFILL18 5MM X 20CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL DLF180520 K10632 10886704076926

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MARVEL® MICROCATHETER (TOKAI MEDICAL PRODUCTS)