BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 3MM X 12CM

    MDR report key: 7718815 · Received July 25, 2018

    Report

    Report Number
    3008114965-2018-00687
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    May 2, 2018
    Report Date
    May 2, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704077190
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE PRODUCT INVESTIGATION COMPLETED ON 7/24/2018, THIS EVENT NOW MEETS THE REQUIRED CRITERIA FOR MDR REPORTING. INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT PROVIDED. PROCODE: KRD/HCG. PHYSICAL MANUFACTURING NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). CONCOMITANT MED PRODUCTS DUE TO CHARACTER LIMITATION: 3MM X 12CM DELTAFILL18 (DLF180312/S14234) THERMO-MECHANICAL COIL. INITIAL REPORTER - THE CUSTOMER CONTACT INFORMATION WAS NOT REPORTED. PHYSICAL MANUFACTURING NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). COMPLAINT CONCLUSION: A REPORT WAS RECEIVED THAT DURING AN EMERGENT COIL EMBOLIZATION PROCEDURE, A 3MM X 12CM DELTAFILL18 (DLF180312/S14234) THERMO-MECHANICAL COIL WAS REMOVED FROM ITS DISPENSER; HOWEVER, IT WAS NOTED THAT THE DELIVERY WIRE WAS OUT AND EXPOSED FROM THE SHEATH. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER DELTAFILL18 FROM THE SAME LOT, BUT THE DELIVERY WIRE WAS ALSO OUT AND EXPOSED WHEN IT WAS REMOVED FROM ITS DISPENSER. THE COIL WAS SUBSEQUENTLY REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. THE INTRODUCER WAS NOT DAMAGED IN ANY WAY. THE USER DID NOT APPLY EXCESSIVE FORCE WHEN HANDLING THE DEVICES. NO FURTHER INFORMATION WAS PROVIDED. TWO DELTAFILL18 COILS WERE RETURNED FOR THIS COMPLAINT IN SEPARATE PACKAGES. THE DEVICES ON THE COMPLAINT ARE THE SAME CATALOG NUMBER AND LOT NUMBER, AND THEY HAVE THE SAME REPORTED ISSUE. THE DEVICES WERE ASSIGNED ARBITRARILY TO THE TWO PRODUCT INVESTIGATIONS. THE EMBOLIC COIL AND DEVICE POSITIONING UNIT (DPU) HAD BEEN REMOVED FROM THE INTRODUCER. THE INTRODUCER AND EMBOLIC COIL/DPU WERE BOTH RETURNED. THE INTRODUCER LOCK WAS DAMAGED. THE RESHEATHING TOOL HAD BEEN ADVANCED ALMOST ALL THE WAY TO THE GREEN INTRODUCER. THERE WAS A KINK IN THE DPU CORE WIRE APPROXIMATELY 6 CM FROM THE PROXIMAL END. THE BALL TIP WAS PRESENT AND INTACT. THE EMBOLIC COIL WAS KINKED. THE ARTICULATING JOINT IS INTACT. THE RESISTANCE HEATING (RH) COIL HAS NOT HEATED. THE INTRODUCER LOCK APPEARS TORN AND KINKED. THE V-NOTCH OF THE RESHEATHING TOOL WAS UNDAMAGED. 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 PRESCORE WAS RUPTURED COULD NOT BE CONFIRMED. THE EMBOLIC COIL AND DPU HAD BEEN REMOVED FROM THE INTRODUCER. BASED ON THE CONDITION OF THE RETURNED DEVICE, IT APPEARS AS THOUGH EXCESSIVE FORCE WAS APPLIED TO THE DPU AND EMBOLIC COIL, POSSIBLY WHILE REMOVING THE DEVICE FROM THE PACKAGING HOOP. THIS EXCESSIVE FORCE DAMAGED THE INTRODUCER LOCK AND ALLOWED THE DPU AND EMBOLIC COIL TO BE PULLED THROUGH THE RESHEATHING TOOL AND OUT OF THE INTRODUCER. ACCORDING TO THE EVENT DESCRIPTION, REMOVAL FROM THE INTRODUCER TOOK PLACE WHILE THE DEVICE WAS BEING REMOVED FROM THE PACKAGING HOOP. THE IFU INSTRUCTS THE USER TO REMOVE THE DEVICE FROM THE PACKAGING HOOP GENTLY AND TO AVOID BENDING THE DPU, AS THIS COULD RESULT IN DAMAGE TO THE DEVICE. THE OBSERVED KINK IN THE DPU CORE WIRE IS LIKELY TO BE A RESULT OF BENDING THE DEVICE WHILE REMOVING IT FROM THE PACKAGING HOOP. 100% OF FINISHED DEVICES ARE INSPECTED FOR THE SECURITY OF THE INTRODUCER LOCK PRIOR TO INSERTING INTO THE PACKAGING HOOP. THIS INSPECTION IS PERFORMED BY APPLYING GENTLE RETRACTION PRESSURE TO THE DPU, AND ENSURING THAT IT IS HELD SECURELY BY THE INTRODUCER LOCK. DAMAGE TO THE INTRODUCER LOCK SUCH AS THAT OBSERVED IN THE RETURNED DEVICE WOULD BE CAUGHT AT THIS STEP. THUS, IT IS VERY UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGE TO THE INTRODUCER LOCK. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW AND THE ANALYSIS OF THE RETURNED PRODUCT, A DEFINITIVE ROOT CAUSE CONCLUSION CANNOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. BASED ON THERE BEING NO REPORT OF EMBOLIC COIL DAMAGE FROM THE USER AND THE RECEIPT OF THE DEVICE OUTSIDE OF THE PROTECTIVE INTRODUCER, IT APPEARS THAT THIS CONDITION, WHICH WOULD BE READILY EVIDENT TO THE USER, LIKELY OCCURRED DURING POST PROCEDURAL HANDLING. WITH REVIEW OF THE ANALYSIS AND THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT OR THE DAMAGES FOUND ON THE 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. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00687 & 3008114965-2018-00688.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING AN EMERGENT COIL EMBOLIZATION PROCEDURE, A 3MM X 12CM DELTAFILL18 (DLF180312/S14234) THERMO-MECHANICAL COIL WAS REMOVED FROM ITS DISPENSER; HOWEVER, IT WAS NOTED THAT THE DELIVERY WIRE WAS OUT AND EXPOSED FROM THE SHEATH. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER DELTAFILL18 FROM THE SAME LOT, BUT THE DELIVERY WIRE WAS ALSO OUT AND EXPOSED WHEN IT WAS REMOVED FROM ITS DISPENSER. THE COIL WAS SUBSEQUENTLY REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. THE INTRODUCER WAS NOT DAMAGED IN ANY WAY. THE USER DID NOT APPLY EXCESSIVE FORCE WHEN HANDLING THE DEVICES. THE PRODUCTS WERE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561388 DELTAFILL18 3MM X 12CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 S14234 10886704077190

    Patients

    Seq Age Sex Outcome Treatment
    1