BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL10 6MM X 16CM

    MDR report key: 12576435 · Received October 5, 2021

    Report

    Report Number
    3008114965-2021-00498
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    April 14, 2021
    Report Date
    October 5, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077107
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE FINDINGS OF THE DEVICE INVESTIGATION. THE EMBOLIC COIL WAS NOTED AS BEING STRETCHED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAFILL10 6MM X 16CM COIL (DLF100616, K10251) BECAME ¿STUCK¿ IN THE GREEN INTRODUCER. NEXT, THE GUIDE GETS OFF THE WHITE SLEEVE. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO MICROCATHETER WAS USED, THE COIL FAILED DURING INSPECTION, PRIOR TO BE INTRODUCED IN THE MICROCATHETER. THE INTRODUCER SLEEVE SEEMED TO BE DAMAGED (CRUSHED) RIGHT AFTER OPENING THE STERILE BAG. THE PLACE IS NEAR THE GREEN INTRODUCER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. A NON-STERILE UNIT DELTAFILL10 6MM X 16CM WAS RECEIVED INSIDE OF A POUCH. THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND THAT THE DPU IS KINKED AT 29 INCHES AND 33 INCHES FROM PROXIMAL, ALSO, THE EMBOLIC COIL WAS PROTRUDED FROM INTRODUCER, NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL INSPECTION. A MICROSCOPIC INSPECTION WAS PERFORMED, AND IT WAS FOUND THAT THE EMBOLIC COIL IS STRETCHED AND PROTRUDED FROM INTRODUCER. THE FUNCTIONAL TEST COULD NOT BE PERFORMED SINCE THE EMBOLIC COIL WAS FOUND STRETCHED AND PROTRUDED FROM INTRODUCER. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE K10251 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. CERENOVUS CONDUCTED A VISUAL AND MICROSCOPIC INSPECTION. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITIONS IN WHICH THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL ANALYSIS OF THE DEVICE, IT WAS NOTED THAT THE DPU IS KINKED, ALSO THE EMBOLIC COIL WAS FOUND PROTRUDED FROM INTRODUCER, NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED DURING THE VISUAL ANALYSIS. PROCEDURAL AND OTHER FACTORS MAY CONTRIBUTE TO THE FINDING; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE DEVICE WAS INSPECTED UNDER A MICROSCOPE, AND IT WAS FOUND THAT THE EMBOLIC COIL IS STRETCHED AND PROTRUDED FROM INTRODUCER, THESE CONDITIONS ARE RELATED TO THE CUSTOMER COMPLAINT REGARDING ¿COIL - IMPEDED-IN INTRODUCER¿. PROCEDURAL AND OTHER FACTORS MAY CONTRIBUTE TO THE FINDING; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. BASED ON THE FINDINGS DURING THE ANALYSIS, THE CUSTOMER COMPLAINT WAS CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IMPEDED IN INTRODUCER IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING RECOMMENDATIONS: ¿ DO NOT FASTEN THE 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 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 DESCRIBED IN ¿MICROCOIL PLACEMENT¿ SECTION ABOVE. ASSIGNMENT OF ROOT CAUSE FOR THE EVENTS REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES ON THE RETURNED SYSTEM. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAFILL10 6MM X 16CM COIL (DLF100616, K10251) BECAME ¿STUCK¿ IN THE GREEN INTRODUCER. NEXT, THE GUIDE GETS OFF THE WHITE SLEEVE. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO MICROCATHETER WAS USED, THE COIL FAILED DURING INSPECTION, PRIOR TO BE INTRODUCED IN THE MICROCATHETER. THE INTRODUCER SLEEVE SEEMED TO BE DAMAGED (CRUSHED) RIGHT AFTER OPENING THE STERILE BAG. THE PLACE IS NEAR THE GREEN INTRODUCER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE ANALYSIS OF THE PRODUCT RECEIVED, THE EMBOLIC COIL IS STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476615 DELTAFILL10 6MM X 16CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL DLF100616 K10251 10886704077107

    Patients

    Seq Age Sex Outcome Treatment
    1