BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 10MM X 40CM

    MDR report key: 8803830 · Received July 18, 2019

    Report

    Report Number
    3008114965-2019-01092
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    May 7, 2019
    Report Date
    May 7, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077114
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPOT THE FINDINGS OF THE DEVICE INVESTIGATION. THE EMBOLIC COIL WAS NOTED TO BEING STRETCHED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL REPORTER PHONE: (B)(6). MANUFACTURING SITE NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A SUBARACHNOID HEMORRHAGE (SAH)COIL EMBOLIZATION OF AN ANEURYSM AT THE IC-TOP, THE PHYSICIAN ATTEMPTED TO INSERT A 10MM X 40CM DELTAFILL18 COIL (DLF181040, S12385) TO THE PATIENT¿S BODY, THE COIL PROTRUDED FROM THE INTRODUCER SHEATH AND THE DELIVERY WIRE COULD NOT ADVANCE. FOURTEEN NON-CERENOVUS COILS WERE IMPLANTED IN THE LESION. THERE WAS NO PATIENT INJURY REPORTED. THE REPORTED EVENT DID NOT RESULT IN A PROCEDURAL DELAY. INITIALLY, AS THE A1 WAS INVOLVED, THE FLOW FROM THE OPPOSITE SIDE WAS CONFIRMED BY A BALLOON OCCLUSION TEST. THEREFORE, A COIL EMBOLIZATION STARTED. THE PHYSICIAN NECK PLASTIED WITH A BALLOON CATHETER AND APPROACHED WITH A MICROCATHETER (SL10) WHICH HAD BEEN STEAM-SHAPED. FIVE COILS (16X50 PRIMEFRAME, 16X50 PRIMEFRAME, 14X45 DELTAFILL18, 14X45 DELTAFILL18, 12X42 DELTAFILL18 WERE IMPLANTED IN THE LESION. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE DEVICE WAS STORED AND HANDLED PER INSTRUCTIONS FOR USE (IFU). THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE USER DID NOT APPLY EXCESSIVE FORCE DURING UNSHEATHING OR RE-SHEATHING. THERE WAS NO DAMAGE FOUND ON ANY PART OF THE ACTUAL COIL DEVICE PRIOR TO USE. NO KINK OR BENT WAS CONFIRMED PRIOR TO USE. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE UNIT DELTAFILL18 10MM X 40CM WAS RECEIVED INSIDE OF A POUCH. THE HUB WAS INSPECTED, AND NO DAMAGES WAS NOTED ON IT. THE DPU WAS INSPECTED AND IT WAS FOUND KINK 34.8CM, 69.5CM, 71.5 AND 72.5CM FROM THE PROXIMAL END. THE INTRODUCER WAS INSPECTED, AND IT WAS FOUND PARTIALLY ZIPPED. THE RE-SHEATING TOOL WAS FOUND WITHOUT DAMAGE. EVEN THOUGH SOME KINKS WERE FOUND ON THE DPU THE MARKER BAND WAS FOUND AT 75CM FROM DISTAL END, AND IT WAS FOUND WITHIN SPECIFICATION. THE V-NOTCH WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND IN NORMAL GOOD CONDITION. THE RH WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND WITHOUT DAMAGE AS WELL WAS NO HEATED. THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND PARTIALLY OUTSIDE OF THE INTRODUCER, THE REST OF THE EMBOLIC COIL WAS FOUND STUCK ON THE RE-SHEATING TOOL. ALSO, THE EMBOLIC COIL WAS FOUND STRETCHED AND WAS FOUND PROTRUDED FROM THE INTRODUCER. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE THE SEVERAL KINKS NOTED ON THE DPU. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE S12385 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE COMPLAINT REPORTED BY THE CUSTOMER ¿COIL INTRODUCER - PRESCORE RUPTURE¿ WAS CONFIRMED DUE THE EMBOLIC COIL WAS FOUND PROTRUDED FROM THE INTRODUCER. THE COMPLAINT REPORTED BY THE CUSTOMER ¿DETACHABLE COIL DELIVERY SYSTEM (DCS)- IMPEDED WITH NO LOSS OF CEREBRAL TARGET POSITION¿ WAS NOT ABLE TO CONFIRM DUE THE SEVERAL KINK CONDITIONS NOTED ON THE DPU. THE KINK CONDITION APPEARS TO HAVE BEEN CAUSED BY EXCESSIVE HANDLING AND FORCE BEING APPLIED TO THE DEVICE HOWEVER NONE OF THOSE CAN BE CONCLUSIVELY DETERMINED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THERE ARE CIRCUMSTANCES OF THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. NEITHER THE ANALYSIS NOR THE MRE SUGGEST THAT THE FAILURE REPORTED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. IMPEDED IN MICROCATHETER IS A KNOWN POTENTIAL PRODUCT FAILURE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU 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. THE IFU ALSO INCLUDES WARNINGS AND INSTRUCTIONS FOR USE TO TROUBLE SHOOT WHEN RESISTANCE IS MET. 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 EVENTS ARE 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 A HEALTHCARE PROFESSIONAL, DURING A SUBARACHNOID HEMORRHAGE (SAH)COIL EMBOLIZATION OF AN ANEURYSM AT THE IC-TOP, THE PHYSICIAN ATTEMPTED TO INSERT A 10MM X 40CM DELTAFILL18 COIL (DLF181040, S12385) TO THE PATIENT¿S BODY, THE COIL PROTRUDED FROM THE INTRODUCER SHEATH AND THE DELIVERY WIRE COULD NOT ADVANCE. FOURTEEN NON-CERENOVUS COILS WERE IMPLANTED IN THE LESION. THERE WAS NO PATIENT INJURY REPORTED. THE REPORTED EVENT DID NOT RESULT IN A PROCEDURAL DELAY. INITIALLY, AS THE A1 WAS INVOLVED, THE FLOW FROM THE OPPOSITE SIDE WAS CONFIRMED BY A BALLOON OCCLUSION TEST. THEREFORE, A COIL EMBOLIZATION STARTED. THE PHYSICIAN NECK PLASTIED WITH A BALLOON CATHETER AND APPROACHED WITH A MICROCATHETER (SL10) WHICH HAD BEEN STEAM-SHAPED. FIVE COILS (16X50 PRIMEFRAME, 16X50 PRIMEFRAME, 14X45 DELTAFILL18, 14X45 DELTAFILL18 AND 12X42 DELTAFILL18) WERE IMPLANTED IN THE LESION. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE DEVICE WAS STORED AND HANDLED PER INSTRUCTIONS FOR USE (IFU). THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE USER DID NOT APPLY EXCESSIVE FORCE DURING UNSHEATHING OR RE-SHEATHING. THERE WAS NO DAMAGE FOUND ON ANY PART OF THE ACTUAL COIL DEVICE PRIOR TO USE. NO KINK OR BENT WAS CONFIRMED PRIOR TO USE. BASED ON THE INVESTIGATION ANALYSIS OF THE DEVICE, THE EMBOLIC COIL WAS FOUND STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596980 DELTAFILL18 10MM X 40CM DELTAFILL KRD MEDOS INTERNATIONAL SARL S12385 10886704077114

    Patients

    Seq Age Sex Outcome Treatment
    1