BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 3MM X 12CM

    MDR report key: 7360423 · Received March 21, 2018

    Report

    Report Number
    3008114965-2018-00575
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    January 1, 2018
    Report Date
    February 1, 2018
    Manufacturer
    SEE H10
    Product Code
    KRD
    UDI-DI
    10886704077190
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SALES REPRESENTED NOTICED A BOX OF OPENED DELTAFIL DETACHABLE COIL SYSTEM (DLF180312, S11193) ON THE SHELF THAT THE TECHNICIAN HAD WRITTEN ON THE BOX ¿UNABLE TO RE-SHEATH¿. THERE WAS NO PATIENT INJURY REPORTED. PER THE FAILURE ANALYSIS LAB, THE EMBOLIC COIL IS KINKED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE EMBOLIC COIL IS LOCATED IN THE TRANSLUCENT INTRODUCER SHEATH. THE DEVICE POSITIONING UNIT (DPU) PROTRUDES FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH BEGINNING NEAR THE MARKER BAND. THE TIP COIL SECTION OF THE DPU IS KINKED NEAR THE MARKER BAND. THERE ARE NO OTHER APPARENT KINKS OR BENDS IN THE DPU CORE WIRE. THE BALL TIP IS INTACT. A SECTION OF THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH IS OPEN OVER THE EMBOLIC COIL. ONE EDGE OF THE SKIVE IS DAMAGED IN THE OPEN SECTION. THE EMBOLIC COIL IS KINKED. THE CONDITION OF THE ARTICULATING JOINT AND RESISTANCE HEATING (RH) COIL ARE OBSCURED BY THE TRANSLUCENT INTRODUCER SHEATH. THERE IS SOME DISCOLORATION ON THE EXTENDED COIL SECTION OF THE DPU, POSSIBLY BLOOD. MICROSCOPIC IMAGE OF THE PROTRUDING TIP COIL SECTION OF THE DPU. THE DPU CORE WIRE PROTRUDES ALL THE WAY TO THE RESHEATHING TOOL. THE V-NOTCH OF THE RESHEATHING TOOL IS UNDAMAGED. THE KINKED AND PROTRUDED DPU PREVENTS THE DEVICE FROM BEING RESHEATHED. 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 OF REZIPPING DIFFICULTY IS CONFIRMED. THE KINK IN THE TIP COIL SECTION OF THE DPU PREVENTS THE TRANSLUCENT INTRODUCER SHEATH FROM RE-FORMING, THUS THE DPU PROTRUDES. THE EVIDENCE OF THE KINKED TIP COIL INDICATES THAT THE RESHEATHING TOOL WAS ADVANCED OVER THE TIP COIL OF THE DPU 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 AND THE MORE FLEXIBLE AND FRAGILE DISTAL SECTIONS OF THE DPU INSIDE THE MICROCATHETER BEFORE CONTINUING TO UNSHEATHE THE DEVICE. IF THE DEVICE IS UNSHEATHED BEFORE ADVANCING INTO THE MICROCATHETER, THERE IS A RISK THAT THE EMBOLIC COIL OR THE DISTAL END OF THE DPU WILL BE UNSHEATHED AND PASS THROUGH THE RESHEATHING TOOL. IF THE RESHEATHING TOOL PASSES OVER THE DISTAL END OF THE DPU, THIS WILL EXPOSE THESE FLEXIBLE SECTIONS, WHICH WILL THEN BE SUBJECT TO KINKING AND BENDING. ONCE A PART OF THE DPU IS KINKED OR BENT, THE TRANSLUCENT INTRODUCER SHEATH WILL NOT BE ABLE TO RE-FORM AROUND IT, AND THAT SECTION OF THE DEVICE WILL PROTRUDE. THE KINK OBSERVED IN THE EMBOLIC COIL MAY HAVE OCCURRED AS PART OF THE SAME UNSHEATHING EVENT. IF THE RESHEATHING TOOL PASSES OVER THE EMBOLIC COIL, IT CAN RESULT IN DAMAGE TO THE EMBOLIC COIL. THE DAMAGE TO THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH OVER THE EMBOLIC COIL MAY BE RELATED TO THE SAME EVENT. ONE-HUNDRED PERCENT (100%) OF DEVICES ARE INSPECTED IN-PROCESS BY ADVANCING THE EMBOLIC COIL OUT OF THE INTRODUCER AND RETRACTING IT BACK. DAMAGE TO THE EMBOLIC COIL PREVENTS THE DEVICE FROM ADVANCING OUT OF THE INTRODUCER, AND WOULD BE REJECTED AT THIS INSPECTION. THUS, IT IS VERY UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED KINK IN THE EMBOLIC COIL. 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 SALES REPRESENTED NOTICED A BOX OF OPENED DELTAFIL DETACHABLE COIL SYSTEM (DLF180312, S11193) ON THE SHELF THAT THE TECHNICIAN HAD WRITTEN ON THE BOX ¿UNABLE TO RE-SHEATH¿. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. PER THE FAILURE ANALYSIS LAB, THE EMBOLIC COIL IS KINKED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202920 DELTAFILL18 3MM X 12CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H10 S11193 10886704077190

    Patients

    Seq Age Sex Outcome Treatment
    1