BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ CERE 2MMX6CM

    MDR report key: 7451740 · Received April 23, 2018

    Report

    Report Number
    3008114965-2018-00602
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    January 31, 2018
    Report Date
    February 1, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    HCG
    UDI-DI
    00878528007098
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE PRODUCT ANALYSIS COMPLETED ON 4/17/2018, THIS PRODUCT EVENT NOW MEETS THE CRITERIA FOR MEDICAL DEVICE REPORTING (MDR). 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)). COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE ADVANCING THE 2MM X 6CM DELTAPAQ (CDF10020630/ S11810) THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM THROUGH THE PROWLER LPES MICROCATHETER. THE COIL DELIVERY SYSTEM GOT STUCK AND COULD NO LONGER ADVANCE. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PROWLER LPES MICROCATHETER WAS NOT REMOVED WITH THE COIL. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE; THEREFORE, THERE WAS NO LOSS OF CEREBRAL TARGET POSITION ASSOCIATED WITH THIS ISSUE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). APPROXIMATELY 3-4 COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER PRIOR TO THIS COIL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION. THE EMBOLIC COIL WAS LOCATED IN THE TRANSLUCENT INTRODUCER SHEATH. THE DEVICE WAS FULLY SHEATHED. THERE WAS A BEND IN THE (DPU) CORE WIRE APPROXIMATELY 88 CM FROM THE PROXIMAL END. THE BALL TIP WAS INTACT. THE EMBOLIC COIL WAS KINKED. THE ARTICULATING JOINT WAS COMPRESSED LONGITUDINALLY. THE CONDITION OF THE (RH) COIL WAS OBSCURED BY THE TRANSLUCENT INTRODUCER SHEATH. THE V-NOTCH OF THE RESHEATHING TOOL WAS UNDAMAGED. AN ATTEMPT WAS MADE TO ADVANCE THE EMBOLIC COIL OUT OF THE INTRODUCER. THE EMBOLIC COIL COULD NOT BE ADVANCED OR RETRACTED. SINCE THE EMBOLIC COIL COULD NOT BE ADVANCED OUT OF THE INTRODUCER, ADVANCEMENT THROUGH A MICROCATHETER COULD NOT BE TESTED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT THAT THE DEVICE WAS IMPEDED IN THE MICROCATHETER WAS CONFIRMED. WHILE THE EMBOLIC COIL COULD NOT BE ADVANCED OR RETRACTED IN THE INTRODUCER, THE OBSERVED DAMAGE TO THE EMBOLIC COIL WOULD ALSO PREVENT IT FROM ADVANCING THROUGH A MICROCATHETER. THE EMBOLIC COIL WAS KINKED AND THE ARTICULATING JOINT WAS COMPRESSED LONGITUDINALLY. THIS IS INDICATIVE OF THE APPLICATION OF EXCESSIVE FORCE, POSSIBLY AN ATTEMPT TO ADVANCE THE DEVICE AGAINST AN IMPEDIMENT OR BLOCKAGE. THE IMPEDIMENT IS NOT OBSERVED IN THE RETURNED DEVICE. THE MICROCATHETER IN USE DURING THE REPORTED EVENT WAS NOT RETURNED. HOWEVER, ACCORDING TO THE UPDATED EVENT DESCRIPTION, THE MICROCATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE, SUGGESTING THAT THERE WAS NO BLOCKAGE PRESENT IN THAT DEVICE. THE IFU CAUTIONS, ¿IF THE INTRODUCER TIP AND MICROCATHETER HUB ARE MISALIGNED, DAMAGE MAY OCCUR TO THE MICROCOIL AS IT PASSES THROUGH THIS TRANSITION.¿ IT IS POSSIBLE THAT THE END OF THE INTRODUCER WAS NOT WELL SEATED IN THE HUB OF THE MICROCATHETER, AND THE OBSERVED DAMAGE OCCURRED AS THE EMBOLIC COIL WAS ADVANCED THROUGH THE HUB OF THE MICROCATHETER. 100% OF DEVICES ARE INSPECTED DURING FINAL ASSEMBLY BY ADVANCING THE EMBOLIC COIL OUT OF THE INTRODUCER AND RETRACTING IT BACK IN. THUS, IT IS UNLIKELY THAT THE EMBOLIC COIL LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGE. WITH REVIEW OF THE ANALYSIS AND THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT OR DAMAGES NOTED ON THE RETURNED SYSTEM. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, BASED ON THE ANALYSIS IT APPEARS THAT PROCEDURAL AND HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES OBSERVED ON THE RETURNED DEVICE. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE ADVANCING THE 2MM X 6CM DELTAPAQ THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM (CDF10020630/ S11810) THROUGH THE PROWLER LPES MICROCATHETER. THE COIL DELIVERY SYSTEM GOT STUCK AND COULD NO LONGER ADVANCE. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PROWLER LPES MICROCATHETER WAS NOT REMOVED WITH THE COIL. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE; THUS, THERE WAS NO LOSS OF CEREBRAL TARGET POSITION ASSOCIATED WITH THE ISSUE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). APPROXIMATELY 3-4 COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER PRIOR TO THIS COIL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THE ASSOCIATED MICROCATHETER WAS DISCARDED AND THUS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293260 DELTAPAQ CERE 2MMX6CM NEUROVASCULAR EMBOLIZATION DEVICE HCG REFER TO SECTION H10 S11810 00878528007098

    Patients

    Seq Age Sex Outcome Treatment
    1