BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 3MM X 12CM

    MDR report key: 8033450 · Received November 2, 2018

    Report

    Report Number
    3008114965-2018-00787
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 12, 2018
    Report Date
    October 12, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704077190
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BRONCHIAL-INTERCOSTAL ARTERY, THE FIFTH SPECTRA COIL FAILED TO DETACH IN THE TARGET LESION. SEVERAL ATTEMPTS WERE MADE TO DETACH THE COIL WITHOUT SUCCESS; THEREFORE, THE ENPOWER CONTROL CABLE (B)(4) WAS REPLACED AND THE COIL WAS DETACHED SUCCESSFULLY. THE 3MM X 12CM DELTAFILL18 (B)(4) THERMO-MECHANICAL COIL WAS THEN CONNECTED TO THE CONTROL CABLE, BUT THE POWER LAMP DID NOT ILLUMINATE. THE COIL WAS REPLACED. TWO ADDITIONAL SPECTRA COILS WERE PLACED. THE 3MM X 6CM DELTAXTRASOFT (B)(4) THERMO-MECHANICAL COIL WAS THEN INSERTED INTO THE PATIENT, BUT THE COIL FAILED TO BE DETACHED DESPITE MULTIPLE ATTEMPTS. THE POWER LAMP WAS ON AND THE CONTROL CABLE WAS NEW. THE COIL WAS REPLACED WITH A SAME-SIZED COIL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COILS WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT NEED FOR ADDITIONAL INTERVENTION. THE EMBOLIC COILS WERE STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE DEVICES WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE COIL DELIVERY SYSTEMS WERE PREPPED AND USED ACCORDING TO THE IFU. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. THE CONNECTING CABLE DID NOT APPEAR DAMAGED. THERE WAS NO REPORT OF A "FAULT" LIGHT ON THE DETACHMENT CONTROL BOX. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. AN EXCELSIOR (B)(4) (STRYKER) MICROCATHETER, CHIKAI (ASAHI INTECC) GUIDEWIRE, AND AN ENPOWER (B)(4) DETACHMENT CONTROL BOX WERE ALSO USED IN THE CASE. NO FURTHER INFORMATION COULD BE OBTAINED. THE 3MM X 12CM DELTAFILL18 WAS RETURNED FOR EVALUATION. THE RETURNED PACKAGING LABEL MATCHED THE COMPLAINT INFORMATION. THE DEVICE WAS RETURNED WITH THE EMBOLIC COIL ADVANCED FROM THE INTRODUCER SHEATH. THE DEVICE POSITIONING UNIT (DPU) CORE WIRE WAS SEEN KINKED AROUND THE DISTAL MARKER BAND. A KINK WAS OBSERVED ON THE DEVICE POSITIONING UNIT (DPU) CORE WIRE APPROXIMATELY 29 CM FROM THE PROXIMAL END OF THE DEVICE. THE DEVICE HAD BEEN UNSHEATHED SO FAR THAT THE PROXIMAL SIDE OF THE GREEN INTRODUCER HAD BEEN BROUGHT WITHIN THE RESHEATHING TOOL, WHICH IS CLOSER THAN THE REQUIRED 2-3 CM OF SPACING AS INSTRUCTED IN THE IFU. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. MULTIPLE KINKS WERE OBSERVED ALONG THE LENGTH OF THE EMBOLIC COIL. THE PROXIMAL END OF THE EMBOLIC COIL WAS SEEN PRESSED INTO THE DISTAL END OF THE DISTAL OUTER SHEATH. THE DISTAL OUTER SHEATH APPEARED TO HAVE NOT BEEN SOFTENED, INDICATING THAT THE DETACHMENT PROCESS HAD NOT BEEN INITIATED. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. A TEAR WAS SEEN IN IN THE DPU PROXIMAL TO THE DISTAL MARKER BAND. THE WIRE IN WHICH THE CURRENT PASSES FROM THE DETACHMENT CONTROL BOX TO THE RESISTANCE HEATING COIL WAS SEEN FRACTURED AND SPLIT. THE DEVICE WAS CONNECTED TO LAB MULTIMETER. THE RESISTANCE WAS MEASURED; HOWEVER, THE OUTPUT READ OPEN LOOP. THE CIRCUIT WITHIN THE DEVICE WAS NOT CLOSED AND COULD NOT RUN A CURRENT THROUGH IT. THE DEVICE WAS CONNECTED TO LAB EQUIPMENT ENPOWER DETACHMENT CONTROL BOX (B)(4) AND ENPOWER CONTROL CABLE (B)(4). THE POWER WAS TURNED ON; HOWEVER, THE SYSTEM READY LIGHT DID NOT ILLUMINATE. THE DETACHMENT PROCESS COULD NOT BE INITIATED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 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 REPORTED CUSTOMER COMPLAINT OF FAILURE TO DETACH WAS CONFIRMED. THE CIRCUIT WITHIN THE DPU WAS DAMAGED AND NO CURRENT COULD PASS THROUGH THE DEVICE TO ACTIVATE THE RESISTANCE HEATING COIL. THE FAILURE TO DETACH WAS CAUSED BY AN OPEN LOOP IN THE DEVICE CIRCUIT. THE CIRCUIT WIRE WITHIN THE DPU PROXIMAL TO THE DISTAL MARKER BAND WAS SEEN FRACTURED AND SPLIT, AND THIS DAMAGE WAS LIKELY THE CAUSE OF THE OPEN LOOP. THE DAMAGE TO THE EMBOLIC COIL, DISTAL OUTER SHEATH, DPU CORE WIRE AND CIRCUIT WAS LIKELY THE RESULT OF EXCESSIVE FORCE APPLIED TO THE DEVICE. THE IFU INSTRUCTS THE USER IN PROPER HANDLING OF THE DEVICE. 100% OF DEVICES ARE INSPECTED IN-PROCESS ALONG THE ENTIRE LENGTH OF THE EMBOLIC COIL AND DPU. IN ADDITION, THE RESISTANCE OF THE DEVICE IS VERIFIED IN-PROCESS TO BE IN SPECIFICATION. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGES. FAILURE TO DETACH IS A KNOWN POTENTIAL PRODUCT FAILURE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU CONTAINS SEVERAL CAUTIONS RELATING TO THIS SITUATION, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. PER THE IFU: ¿VERIFY THAT THE MICROCOIL DELIVERY SYSTEM IS FULLY CONNECTED AND NO FAULTS ARE INDICTED ON THE DCB. IF A FAULT EXISTS, RESEAT ALL CONNECTIONS BETWEEN THE DPU, THE DCB, AND THE CONNECTING CABLE. IF A FAULT STILL PERSISTS, REPLACE THE CONNECTING CABLE. IF THIS DOES NOT CORRECT THE ERROR, REPLACE THE DCB. IF THE MICROCOIL DELIVERY SYSTEM STILL CONTINUES TO HAVE A FAULT, RETRIEVE THE MICROCOIL AS DESCRIBED IN THE FOLLOWING SECTION, RE SHEATHING THE MICROCOIL SYSTEM, AND REPLACE WITH A NEW MICROCOIL SYSTEM.¿ NEITHER THE PRODUCT ANALYSIS NOR THE DEVICE HISTORY REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE MINIMAL INFORMATION PROVIDED AND EVIDENCE PRESENTED BY THE RETURNED SAMPLE; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS, INCLUDING DEVICE MANIPULATION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE TO DETACH AND DAMAGES NOTED TO THE RETURNED SYSTEM. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00787 & 3008114965-2018-00788.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT PROVIDED. PROCODE: KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). CONCOMITANT MED PRODUCTS DUE TO CHARACTER LIMITATION: EXCELSIOR 1018 (STRYKER) MICROCATHETER, CHIKAI (ASAHI INTECC) GUIDEWIRE, AND ENPOWER (DCB2) DCB2000500 DETACHMENT CONTROL BOX. (B)(6). PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBER ARE 3008114965-2018-00788.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BRONCHIAL-INTERCOSTAL ARTERY, THE FIFTH SPECTRA COIL FAILED TO DETACH IN THE TARGET LESION. SEVERAL ATTEMPTS WERE MADE TO DETACH THE COIL WITHOUT SUCCESS; THEREFORE, THE ENPOWER CONTROL CABLE (ECB000182-00/S14572) WAS REPLACED AND THE COIL WAS DETACHED SUCCESSFULLY. THE 3MM X 12CM DELTAFILL18 (DLF180312/S14732) THERMO-MECHANICAL COIL WAS THEN CONNECTED TO THE CONTROL CABLE, BUT THE POWER LAMP DID NOT ILLUMINATE. THE COIL WAS REPLACED. TWO ADDITIONAL SPECTRA COILS WERE PLACED. THE 3MM X 6CM DELTAXTRASOFT (DLX100306/S14197) THERMO-MECHANICAL COIL WAS THEN INSERTED INTO THE PATIENT, BUT THE COIL FAILED TO BE DETACHED DESPITE MULTIPLE ATTEMPTS. THE POWER LAMP WAS ON AND THE CONTROL CABLE WAS NEW. THE COIL WAS REPLACED WITH A SAME-SIZED COIL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE COIL DELIVERY SYSTEMS WERE PREPPED AND USED ACCORDING TO THE IFU. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. THE CONNECTING CABLE DID NOT APPEAR DAMAGED. THERE WAS NO REPORT OF A "FAULT" LIGHT ON THE DETACHMENT CONTROL BOX. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE COILS WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT NEED FOR ADDITIONAL INTERVENTION. THE EMBOLIC COILS WERE STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. AN EXCELSIOR 1018 (STRYKER) MICROCATHETER, CHIKAI (ASAHI INTECC) GUIDEWIRE, AND AN ENPOWER DCB2000500 DETACHMENT CONTROL BOX WERE ALSO USED IN THE CASE. THE COMPLAINT COILS WILL BE RETURNED FOR EVALUATION. THE COMPLAINT CABLE IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875200 DELTAFILL18 3MM X 12CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 S14732 10886704077190

    Patients

    Seq Age Sex Outcome Treatment
    1