BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 HELICAL XTRASOFT COIL 2X4

    MDR report key: 7797578 · Received August 20, 2018

    Report

    Report Number
    3008114965-2018-00718
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Date of Event
    August 2, 2018
    Report Date
    August 3, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10878528009396
    PMA / PMN Number
    K120686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BASILAR TIP ARTERY ANEURYSM, THE 2MM X 4CM G2 HELICAL XTRASOFT (B)(4) THERMO-MECHANICAL COIL DELIVERY SYSTEM WAS ADVANCED THROUGH THE BODY/SHAFT OF THE ECHELON (MEDTRONIC) MICROCATHETER, BUT RESISTANCE WAS ENCOUNTERED, AND THE COIL DELIVERY SYSTEM COULD NOT BE ADVANCED. THE COIL WAS REMOVED FROM THE MICROCATHETER; HOWEVER, UPON RETRIEVAL OF THE COIL, THE USER NOTED THAT THE COIL HAD DETACHED INSIDE OF THE MICROCATHETER HUB. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. PRIOR TO THIS COIL, THREE COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE USER DID NOT FASTEN THE ROTATING HEMOSTATIC VALVE (RHV) TOO TIGHTLY AROUND THE INTRODUCER. THE USER CONTINUOUSLY VERIFIED THAT THE INTRODUCER TIP AND THE MICROCATHETER HUB REMAINED ALIGNED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. WHEN THE UNUSUAL FRICTION OCCURRED DURING ADVANCEMENT, THE USER VERIFIED THAT THE FLUSH LINES WERE OPEN AND PROPERLY PRESSURIZED. NO ADDITIONAL DAMAGE WAS NOTED TO THE EMBOLIC COIL. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE CASE. NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCT WAS RETURNED WITH THE EMBOLIC COIL DETACHED FROM THE DEVICE. THE PACKAGING LABEL RETURNED WITH THE DEVICE MATCHED THE COMPLAINT INFORMATION. THE DEVICE WAS RETURNED PARTIALLY UNSHEATHED AS INDICATED BY THE LENGTH OF THE INTRODUCER PROXIMAL TO THE RESHEATHING TOOL. THE DISTAL END OF THE DEVICE POSITIONING UNIT (DPU) CORE WIRE WAS SEEN IN THE GREEN INTRODUCER. THE DPU CORE WIRE WAS SEEN KINKED AT APPROXIMATELY 27 CM FROM THE PROXIMAL END OF THE DEVICE. THE DEVICE WAS RETURNED WITH THE MAJORITY OF THE DPU CORE WIRE DISTAL TO THE RESHEATHING TOOL OUT OF THE INTRODUCER. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. THE EMBOLIC COIL WAS SEEN KINKED AT SEVERAL LOCATIONS. THE SOCKET RING WAS FOUND INTACT. THE DPU ORE WIRE WAS SEEN PROTRUDING FROM THE SKIVE OF THE INTRODUCER. NO KINKS TO THE DPU CORE WIRE WERE FOUND AT THE POINT OF PROTRUSION. THE DPU CORE WIRE ENTERED THE DISTAL END OF THE RESHEATHING TOOL OUTSIDE OF THE INTRODUCER. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. THE DISTAL OUTER SHEATH WAS SEEN TO NOT HAVE BEEN SOFTENED, INDICATING THAT THE DETACHMENT WAS NOT CAUSED BY PRESSING THE DETACHMENT BUTTON ON THE DETACHMENT CONTROL BOX/CONTROL CABLE AND HEATING THE RESISTANCE HEATING (RH) COIL. THE COIL INSIDE THE DISTAL OUTER SHEATH WAS SEEN DEFORMED AND NOT ALIGNED WITH THE SHEATH. THE DISTAL END OF THE DISTAL OUTER SHEATH WAS SEEN COVERED WITH A BLOOD-LIKE PARTICULATE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. 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 PREMATURE DETACHMENT WAS CONFIRMED. THE DETACHMENT PROCESS WAS NOT INITIATED BECAUSE THE DISTAL OUTER SHEATH WAS SEEN NOT SOFTENED (INDICATING THAT THE RESISTANCE HEATING COIL HAD NOT BEEN HEATED); THUS, THE EMBOLIC COIL WAS MECHANICALLY DETACHED. THE REPORTED CUSTOMER COMPLAINT OF IMPEDED IN MICROCATHETER COULD NOT BE CONFIRMED. THE DEVICE COULD NOT BE TESTED IN A MICROCATHETER BECAUSE THE COIL HAD BEEN DETACHED. WITHOUT THE RETURN OF THE CONCOMITANT MICROCATHETER, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE DETACHMENT OF THE EMBOLIC COIL WAS LIKELY THE RESULT OF EXCESSIVE FORCE APPLIED TO THE DEVICE DURING RETRACTION. FORCE WAS ALSO INDICATED BY THE DAMAGED DISTAL END OF THE CORE WIRE WITHIN THE DISTAL OUTER SHEATH, THE KINKS IN THE CORE WIRE, AND THE KINKS IN THE EMBOLIC COIL. THE INSTRUCTIONS FOR USE (IFU) PROVIDES INSTRUCTIONS WHEN RESISTANCE IS FELT DURING ADVANCEMENT OF THE DEVICE. THE BLOOD-LIKE PARTICULATE SEEN AROUND THE DISTAL OUTER SHEATH SUGGESTS THAT AN INSUFFICIENT FLUSH WAS MAINTAINED. THE IFU ALSO STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND ALSO INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. 100% OF DEVICES ARE INSPECTED FOR DAMAGE AND IRREGULARITIES ALONG THE FULL LENGTH OF THE EMBOLIC COIL, AROUND THE ARTICULATING JOINT INCLUDING THE PET SHEATH, AND THROUGHOUT THE DPU CORE WIRE. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED ISSUES. IMPEDED IN MICROCATHETER AND PREMATURE DETACHMENT ARE KNOWN POTENTIAL PRODUCT FAILURES 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. NEITHER THE PRODUCT ANALYSIS NOR THE DEVICE HISTORY RECORD REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS, INCLUDING DEVICE MANIPULATION, INSUFFICIENT FLUSH, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES NOTED ON 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    (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. (FREMONT) (B)(6). (B)(4). THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. 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.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BASILAR TIP ARTERY ANEURYSM, THE 2MM X 4CM G2 HELICAL XTRASOFT (641HX0204/S13639) THERMO-MECHANICAL COIL DELIVERY SYSTEM WAS ADVANCED THROUGH THE BODY/SHAFT OF THE ECHELON (MEDTRONIC) MICROCATHETER, BUT RESISTANCE WAS ENCOUNTERED, AND THE COIL DELIVERY SYSTEM COULD NOT BE ADVANCED. THE COIL WAS REMOVED FROM THE MICROCATHETER; HOWEVER, UPON RETRIEVAL OF THE COIL, THE USER NOTED THAT THE COIL HAD DETACHED INSIDE OF THE MICROCATHETER HUB. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. PRIOR TO THIS COIL, THREE COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE USER DID NOT FASTEN THE ROTATING HEMOSTATIC VALVE (RHV) TOO TIGHTLY AROUND THE INTRODUCER. THE USER CONTINUOUSLY VERIFIED THAT THE INTRODUCER TIP AND THE MICROCATHETER HUB REMAINED ALIGNED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. WHEN THE UNUSUAL FRICTION OCCURRED DURING ADVANCEMENT, THE USER VERIFIED THAT THE FLUSH LINES WERE OPEN AND PROPERLY PRESSURIZED. NO ADDITIONAL DAMAGE WAS NOTED TO THE EMBOLIC COIL. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE CASE. THE COMPLAINT PRODUCT WILL BE RETURNED FOR EVALUATION. THE CONCOMITANT MICROCATHETER WAS DISCARDED BY THE CUSTOMER AND IS THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640604 G2 HELICAL XTRASOFT COIL 2X4 NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 S13639 10878528009396

    Patients

    Seq Age Sex Outcome Treatment
    1 ECHELON (MEDTRONIC) MICROCATHETER