BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL10 3MM X 10CM

    MDR report key: 7818462 · Received August 27, 2018

    Report

    Report Number
    3008114965-2018-00725
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 8, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704077039
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A MODERATELY TORTUOUS VESSEL, THE PHYSICIAN STARTED TO DEPLOY THE 3MM X 10CM DELTAFILL10 (DLF100310/S11155) THERMO-MECHANICAL COIL WHEN HE NOTICED THAT IT WAS FRAYED. THE COIL WAS REMOVED FROM THE SL-10 (STRYKER) MICROCATHETER. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. NO ADDITIONAL INTERVENTION WAS REQUIRED TO PREVENT IMPAIRMENT. NO FURTHER INFORMATION WAS PROVIDED. THE 3MM X 10CM DELTAFILL10 WAS RETURNED FOR EVALUATION. THE RETURNED PACKAGE LABEL MATCHED THE COMPLAINT INFORMATION. THE INTRODUCER WAS OBSERVED TO BE FRAYED IN TO TWO STRANDS AND STUCK IN THE V-NOTCH OF THE RESHEATHING TOOL. ONE STRAND OF THE INTRODUCER WAS OBSERVED TO GO THROUGH THE PROXIMAL END OF THE RESHEATHING TOOL WHILE THE OTHER EXITED THROUGH THE NORMAL OPENING. THE EMBOLIC COIL WAS RETURNED INSIDE THE GREEN INTRODUCER. THE DEVICE POSITIONING UNIT (DPU) CORE WIRE WAS KINKED AT APPROXIMATELY 5 CM FROM THE PROXIMAL END OF THE DEVICE. USING A MICROSCOPE, THE INTRODUCER WAS OBSERVED TO BE LODGED IN THE V-NOTCH OF THE RESHEATHING TOOL. THE INTRODUCER WAS REMOVED FROM THE V-NOTCH AND THE V-NOTCH WAS OBSERVED TO BE FRACTURED. THE EMBOLIC COIL BALL TIP WAS SEEN PRESENT AND INTACT. THE DISTAL OUTER SHEATH HAD NOT BEEN SOFTENED, INDICATING THAT THE DETACHMENT PROCESS HAD NOT BEEN INITIATED. THE PROXIMAL END OF THE EMBOLIC COIL WAS SEEN TO BE STRETCHED UP TO THE SOCKET RING. NO OTHER IRREGULARITIES WERE SEEN ON THE EMBOLIC COIL. ARTICULATING JOINT WAS OBSERVED TO BE INTACT. 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 COIL DAMAGE WAS CONFIRMED; HOWEVER, THE EXACT CIRCUMSTANCES SURROUNDING THE OBSERVED DAMAGE CANNOT BE DETERMINED BASED ON THE CONDITION OF THE RETURNED DEVICE. THE EMBOLIC COIL WAS STRETCHED AT ITS PROXIMAL END. THE COMPLAINT STATES THAT THE DEVICE WAS REMOVED FROM THE MICROCATHETER, SO THE STRETCHING MAY HAVE OCCURRED SOMETIME DURING RETRACTION OF THE DEVICE BECAUSE OF EXCESSIVE PULL FORCE. THE FRAYED INTRODUCER INDICATES THAT THE DEVICE WAS NOT PROPERLY UNLOCKED. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE FOLLOWING TO PROPERLY UNSHEATHE THE DEVICE: ¿GRASP THE DISTAL END OF THE RE-SHEATHING TOOL BETWEEN YOUR LEFT THUMB AND FOREFINGER. GRASP THE CLEAR TAB NEAR THE PROXIMAL END OF THE INTRODUCER SHEATH BODY WITH THE THUMB AND FOREFINGER OF YOUR OTHER HAND. GENTLY PULL THE CLEAR TAB OF THE INTRODUCER SHEATH OUT AND AWAY FROM THE RE-SHEATHING TOOL AT A 45-DEGREE ANGLE TO UNLOCK THE MICROCOIL. CONTINUE TO PULL THE TAB UNTIL AN ADDITIONAL 0.5 TO 1.0 IN (1.3 TO 2.5 CM) OF THE TRANSLUCENT MATERIAL IS EXPOSED. GENTLY FOLD THE TRANSLUCENT TAB TOWARDS THE DISTAL END, AND FIRMLY GRASP THE DISTAL END OF THE RE-SHEATHING TOOL AND THE TRANSLUCENT TAB BETWEEN YOUR THUMB AND FOREFINGER¿. PULLING THE TAB STRAIGHT OUT (IN PARALLEL TO THE DPU) WILL RESULT IN DAMAGE TO THE RESHEATHING TOOL AND MAY CAUSE DAMAGE TO THE EMBOLIC COIL. 100% OF DEVICES ARE TESTED FOR SHEATHING FUNCTIONALITY DURING MANUFACTURING. ALSO, 100% OF DEVICES ARE INSPECTED FOR IRREGULARITIES TO THE EMBOLIC COIL SUCH AS STRETCHING. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGE. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE EVENT AS REPORTED. 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 THE EVIDENCE PRESENTED BY THE SAMPLE ARTICLE; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS, INCLUDING DEVICE MANIPULATION AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND ADDITIONAL 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. 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

    PRODUCT COMPLAINT # (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT 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 · 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. ((B)(4)). INITIAL REPORTER - THE CUSTOMER CONTACT INFORMATION, INCLUDING OCCUPATION, FAX, AND E-MAIL ADDRESS WAS NOT REPORTED. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE (WHICH IS INDICATED AS "OTHER"). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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 MODERATELY TORTUOUS VESSEL, THE PHYSICIAN STARTED TO DEPLOY THE 3MM X 10CM DELTAFILL10 (DLF100310/S11155) THERMO-MECHANICAL COIL WHEN HE NOTICED THAT IT WAS FRAYED. THE COIL WAS REMOVED FROM THE SL-10 (STRYKER) MICROCATHETER. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. NO ADDITIONAL INTERVENTION WAS REQUIRED TO PREVENT IMPAIRMENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657384 DELTAFILL10 3MM X 10CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 S11155 10886704077039

    Patients

    Seq Age Sex Outcome Treatment
    1 SL-10 (STRYKER) MICROCATHETER