BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAXSFT10 2.5MM X 6CM

    MDR report key: 7395607 · Received April 4, 2018

    Report

    Report Number
    3008114965-2018-00590
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    January 1, 2017
    Report Date
    December 7, 2017
    Manufacturer
    SEE H10
    Product Code
    KRD
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). MANUFACTURER NAME: (B)(4). INITIAL REPORTER'S PHONE: (B)(6). INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN ANEURYSM (TARGET UNKNOWN), IT WAS DIFFICULT TO IMPLEMENT AGAIN A DELTAXSFT COIL (DLX100256, C41706) INTO THE SHEATH. THERE WERE NO PATIENT CONSEQUENCES. PER THE DEVICE ANALYSIS, THE EMBOLIC COIL IS KINKED AND THE PROTRUDED SECTION OF EMBOLIC COIL IS STRETCHED. IMAGE OF THE DEVICE AS RETURNED. THE DEVICE POSITIONING UNIT (DPU) IS TIGHTLY COILED AND KNOTTED. THE DEVICE WAS GENTLY UNTIED. AFTER UNTYING, TWO LOOPS REMAIN BENT INTO THE DPU CORE WIRE. THE DISTAL END OF THE EMBOLIC COIL IS LOCATED IN THE TRANSLUCENT INTRODUCER SHEATH. THERE IS A LOOP OF EMBOLIC COIL PROTRUDING FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH. IN ADDITION TO THE LOOPS CAUSED BY TYING THE DEVICE, THERE IS A KINK IN THE DPU CORE WIRE APPROXIMATELY 160 CM FROM THE PROXIMAL END. THE BALL TIP IS INTACT. THE EMBOLIC COIL IS KINKED. THE PROTRUDED SECTION OF EMBOLIC COIL IS STRETCHED. THE CONDITION OF THE ARTICULATING JOINT AND RESISTANCE HEATING (RH) COIL ARE OBSCURED BY THE TRANSLUCENT INTRODUCER SHEATH. THE MARKER BAND HAS BEEN UNSHEATHED AND IS VISIBLE IN THE V-NOTCH OF THE RESHEATHING TOOL. THE V-NOTCH OF THE RESHEATHING TOOL IS DAMAGED. THE TIP COIL SECTION OF THE DPU EXITS THE RESHEATHING TOOL. THE DEVICE CANNOT BE RESHEATHED BECAUSE A SECTION OF EMBOLIC COIL PROTRUDES FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH. 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 IS IMPEDED IN THE INTRODUCER IS CONFIRMED. BECAUSE A SECTION OF THE EMBOLIC COIL IS PROTRUDING FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH, THE DEVICE CANNOT BE ADVANCED OR RETRACTED. THE EVIDENCE OF THE PROTRUDED EMBOLIC COIL INDICATES THAT THE RESHEATHING TOOL WAS ADVANCED OVER THE EMBOLIC COIL WHILE UNSHEATHING THE DEVICE. THE IFU (LCN 208535-001 REV. C) INSTRUCTS THE USER TO UNSHEATHE A SMALL LENGTH OF THE DPU TO UNLOCK THE DEVICE, THEN TO ADVANCE THE EMBOLIC COIL INTO THE MICROCATHETER UNTIL THE HUB CONNECTOR OF THE DPU REACHES THE PROXIMAL END OF THE RESHEATHING TOOL. THIS RESULTS IN THE PLACEMENT OF THE EMBOLIC COIL INSIDE THE MICROCATHETER BEFORE CONTINUING TO UNSHEATHE THE DEVICE. IF THE DEVICE IS UNSHEATHED BEFORE ADVANCING THE EMBOLIC COIL INTO THE MICROCATHETER, THERE IS A RISK THAT THE EMBOLIC COIL WILL BE UNSHEATHED AND PASS THROUGH THE RESHEATHING TOOL. THIS CAN CAUSE DAMAGE TO THE EMBOLIC COIL AND CAN ALSO CAUSE IT TO PROTRUDE FROM THE INTRODUCER. THE KINKS OBSERVED IN THE EMBOLIC COIL MAY HAVE ALSO OCCURRED WHILE THE EMBOLIC COIL WAS UNSHEATHED. IT IS ALSO POSSIBLE THAT THE KINKS OCCURRED WHEN EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE BEND IN THE DPU CORE WIRE IS INDICATIVE OF EXCESSIVE FORCE BEING APPLIED TO THE DEVICE, POSSIBLY IN AN ATTEMPT TO OVERCOME THE REPORTED RESISTANCE. IN ADDITION, DAMAGE TO THE V-NOTCH OF THE RESHEATHING TOOL INDICATES THAT THE DEVICE WAS NOT PROPERLY UNLOCKED. THE IFU INSTRUCTS THE USER TO UNLOCK THE DEVICE BY GENTLY PULLING THE CLEAR TAB OF THE INTRODUCER SHEATH OUT AND AWAY FROM THE RE-SHEATHING TOOL AT A 45-DEGREE ANGLE. PULLING THE TAB STRAIGHT OUT (IN PARALLEL TO THE DPU) REQUIRES THE APPLICATION OF EXCESSIVE FORCE, AND WILL RESULT IN DAMAGE TO THE RESHEATHING TOOL. IT MAY ALSO CAUSE DAMAGE TO THE EMBOLIC COIL. 100% OF DEVICES ARE INSPECTED IN-PROCESS BY ADVANCING THE EMBOLIC COIL OUT OF THE INTRODUCER, THEN RETRACTING IT BACK SO IT IS VERY UNLIKELY THAT THE OBSERVED DAMAGE TO THE EMBOLIC COIL WAS PRESENT WHEN THE DEVICE LEFT THE MANUFACTURING FACILITY. 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 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 · 1

    AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN ANEURYSM (TARGET UNKNOWN), IT WAS DIFFICULT TO IMPLEMENT AGAIN A DELTAXSFT COIL (DLX100256, C41706) INTO THE SHEATH. THERE WERE NO PATIENT CONSEQUENCES. THE PRODUCT WILL BE RETURN FOR ANALYSIS. PER THE DEVICE ANALYSIS, THE EMBOLIC COIL IS KINKED AND THE PROTRUDED SECTION OF EMBOLIC COIL IS STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240708 DELTAXSFT10 2.5MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1