BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 12MM X 42CM

    MDR report key: 7712958 · Received July 23, 2018

    Report

    Report Number
    3008114965-2018-00685
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Date of Event
    July 10, 2018
    Report Date
    July 10, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704077121
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. (B)(4). PRODUCT WAS RECEIVED AND IS PENDING EVALUATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT ONCE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT EVENT OCCURRED DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A RECANALIZED INTERNAL CAROTID ARTERY PARACLINOID ANEURYSM. THE INITIAL TREATMENT WAS PERFORMED IN (B)(6) 2018, A NEUROFORM ATLAS COIL (STRYKER) WAS IMPLANTED. DURING THE RE-TREATMENT PROCEDURE, AFTER THE FIRST COIL WAS IMPLANTED AND THE DELIVERY WIRE WAS WITHDRAWN. IT WAS REPORTED THEN THAT THERE WAS SOME RESISTANCE EXPERIENCED AROUND THE Y-CONNECTOR AREA. THE DELTAFILL 18 12MMX 42CM COIL (DLF181242 / S13346) WAS THE SECOND COIL SELECTED; IT WAS INSERTED INTO THE MICROCATHETER, RESISTANCE WAS EXPERIENCED AT THE HUB AND THE COIL COULD NOT ADVANCE IN THE MICROCATHETER. THE PHYSICIAN VISUALLY INSPECTED THE HUB AND CONFIRMED THAT THERE WAS A FOREIGN MATERIAL IN THE HUB. THE DISTAL END OF THE DELTAFILL COIL WAS EXAMINED AND IT WAS DISCOVERED THAT THE DISTAL END OF THE DELIVERY WIRE HAD PEELED OFF AND BECAME SEPARATED; THE FOREIGN MATERIAL NOTED IN THE HUB BY THE PHYSICIAN WAS THE SEPARATED FRAGMENT OF THE DELIVERY WIRE AND THIS CAUSED A BLOCK IN THE MICROCATHETER AND IMPEDED THE COIL FROM FURTHER ADVANCING IN THE MICROCATHETER. THE PHYSICIAN COMMENTED THAT THE Y-CONNECTOR MIGHT HAVE BEEN OVERTIGHTENED AND BEEN CLOSED AFTER THE FIRST COIL WAS IMPLANTED. THE TERUMO HEADWAY DUO MICROCATHETER WAS REPLACED WITH THE SL 10 (STRYKER) MICROCATHETER AND ADDITIONAL COILS WERE SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE DELTAFILL 18 12MMX 42CM COIL WAS RETURNED FOR ANALYSIS; THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: DEVICE RETURNED WITH THE HEADWAY DUO MICROCATHETER. THE DEVICE WAS UNSHEATHED, AS INDICATED BY THE LENGTH OF THE INTRODUCER PROXIMAL OF THE RESHEATHING TOOL. THE DEVICE POSITIONING UNIT (DPU) CORE WIRE HAD BEEN BROKEN AND SEPARATED INTO TWO SEGMENTS AT APPROXIMATELY 113 CM FROM ITS PROXIMAL END AND JUST DISTAL OF THE MARKER BAND. DEVICE POSITIONING UNIT (DPU) CORE WIRE HAD SUSTAINED NO OTHER KINKS OR DAMAGE. THE MICROCATHETER WAS RETURNED WITH NO OBSERVED DAMAGE. THE BROKEN DISTAL SEGMENT OF THE DEVICE WAS SEEN STUCK AT THE PROXIMAL END OF THE MICROCATHETER, INSIDE THE HUB ENTRANCE. THE DISTAL END OF THE DEVICE CAN BE SEEN BROKEN WITH LOOSE WIRES. THE DEVICE CAN BE SEEN WITH A DAMAGED MARKER BAND. THE V-NOTCH OF THE RESHEATHING TOOL IS UNDAMAGED. THE MICROCATHETER IS SEEN TO HAVE THE DISTAL SEGMENT OF THE DEVICE STUCK AT ITS DISTAL END. DISTAL SEGMENT OF THE DEVICE UNABLE TO BE COMPLETELY OBSERVED BECAUSE IT IS OBSCURED INSIDE THE MICROCATHETER. ALSO, THE COMPLAINT DESCRIPTION MENTIONS THAT THE EMBOLIC COIL WAS LEFT IMPLANTED IN THE PATIENT. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (S13346) 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. INVESTIGATION CONCLUSION: THE COMPLAINT OF DETACHABLE COIL DELIVERY SYSTEM (DCS) RESISTANCE/FRICTION-DURING WITHDRAWAL WITH NO LOSS OF CEREBRAL TARGET POSITION IS CONFIRMED. THE DEVICE HAD BEEN BROKEN INTO TWO SEGMENTS AND THE DISTAL SEGMENT WAS OBSERVED STUCK IN THE ENTRANCE TO THE PROXIMAL END OF THE MICROCATHETER AND WAS UNABLE TO BE REMOVED. THE COMPLAINT DESCRIPTION MENTIONS THAT RESISTANCE WAS FELT AROUND THE Y-CONNECTOR AREA UPON WITHDRAWAL OF THE COIL, AND THE PHYSICIAN COMMENTED ON THE TIGHTNESS OF THE Y-CONNECTOR. EXCESSIVE FORCE APPLIED TO THE DEVICE WHILE ATTEMPTING TO REMOVE IT THROUGH THE Y-CONNECTOR IS LIKELY THE CAUSE OF SEPARATION. THE WIRES AT THE DEVICE SEPARATION INDICATE A BREAK BY PULL FORCE RATHER THAN BEING CUT. THE MARKER BAND WAS ALSO LIKELY DAMAGED AS A RESULT OF DEVICE REMOVAL THROUGH THE OVERLY TIGHTENED CONNECTOR AREA. THE INSTRUCTION FOR USE (IFU) CAUTIONS AGAINST OVERTIGHTENING THE ROTATING HEMOSTAT VALVE (RHV) VALVE AND STATES THE FOLLOWING: ¿CAUTION: 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.¿ THE REPORTED ISSUE IN THE COMPLAINT THAT THE DELTAFILL 18 12MMX 42CM COIL EXPERIENCED RESISTANCE AT THE HUB OF THE MICROCATHETER AND THE COIL COULD NOT BE ADVANCED IN THE MICROCATHETER WAS CONFIRMED DURING THE FUNCTIONAL TESTING OF THE RETURNED DEVICE. IT WAS ALSO CONFIRMED THAT THE DEVICE HAD BEEN BROKEN INTO TWO SEGMENTS. THE DISTAL END OF THE DELIVERY WIRE WAS CONFIRMED TO BE BROKEN; THE DISTAL SEGMENT OF THE DEVICE WAS OBSERVED STUCK AT THE DISTAL END OF THE MICROCATHETER. THE LIKELY CAUSE OF THE BROKEN SEGMENTS IS APPLIED EXCESSIVE FORCE DURING THE ATTEMPT TO REMOVE THE DEVICE THROUGH THE Y-CONNECTOR. THE WIRES AT THE DEVICE SEPARATION INDICATE A BREAK BY A PULLING FORCE RATHER THAN BEING CUT. THE DAMAGED MARKER BAND ALSO INDICATE THAT DURING THE DEVICE REMOVAL, THE DEVICE PASSED THROUGH THE OVERLY TIGHTENED CONNECTOR AREA. BASED ON THE DEVICE HISTORY RECORD 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. DEVICE HISTORY LOT: A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (S13346) 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. 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 · 1

    (B)(4). INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG.. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). CONCOMITANT PRODUCTS: GUIDEWIRE (TERUMO, TRAXESS), TWO GUIDING CATHETERS (8F, FUBUKI ¿ ASAHI INTECC), Y-CONNECTOR (ABBOTT), MICROCATHETERS (TERUMU, HEADWAY DUO AND STRYKER, SL-10), ENPOWER CABLE, DCB02 DETACHMENT CONTROL BOX. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT EVENT OCCURRED DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A RECANALIZED INTERNAL CAROTID ARTERY PARACLINOID ANEURYSM. THE INITIAL TREATMENT WAS PERFORMED IN (B)(6) 2018, A NEUROFORM ATLAS COIL (STRYKER) WAS IMPLANTED. DURING THE RE-TREATMENT PROCEDURE, AFTER THE FIRST COIL WAS IMPLANTED AND THE DELIVERY WIRE WAS WITHDRAWN. IT WAS REPORTED THEN THAT THERE WAS SOME RESISTANCE EXPERIENCED AROUND THE Y-CONNECTOR AREA. THE DELTAFILL 18 12MMX 42CM COIL (DLF181242 / S13346) WAS THE SECOND COIL SELECTED; IT WAS INSERTED INTO THE MICROCATHETER, RESISTANCE WAS EXPERIENCED AT THE HUB AND THE COIL COULD NOT ADVANCE IN THE MICROCATHETER. THE PHYSICIAN VISUALLY INSPECTED THE HUB AND CONFIRMED THAT THERE WAS A FOREIGN MATERIAL IN THE HUB. THE DISTAL END OF THE DELTAFILL COIL WAS EXAMINED AND IT WAS DISCOVERED THAT THE DISTAL END OF THE DELIVERY WIRE HAD PEELED OFF AND BECAME SEPARATED; THE FOREIGN MATERIAL NOTED IN THE HUB BY THE PHYSICIAN WAS THE SEPARATED FRAGMENT OF THE DELIVERY WIRE AND THIS CAUSED A BLOCK IN THE MICROCATHETER AND IMPEDED THE COIL FROM FURTHER ADVANCING IN THE MICROCATHETER. THE PHYSICIAN COMMENTED THAT THE Y-CONNECTOR MIGHT HAVE BEEN OVERTIGHTENED AND BEEN CLOSED AFTER THE FIRST COIL WAS IMPLANTED. THE TERUMO HEADWAY DUO MICROCATHETER WAS REPLACED WITH THE SL 10 (STRYKER) MICROCATHETER AND ADDITIONAL COILS WERE SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554589 DELTAFILL18 12MM X 42CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 S13346 10886704077121

    Patients

    Seq Age Sex Outcome Treatment
    1