BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL18 9MM X 35CM

    MDR report key: 7887533 · Received September 18, 2018

    Report

    Report Number
    3008114965-2018-00740
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    June 22, 2018
    Report Date
    June 22, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704077237
    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 EMBOLIC COIL DAMAGE NOTED DURING THE PRODUCT INVESTIGATION, THIS EVENT MEETS THE REQUIRED CRITERIA FOR MDR REPORTING. PROCODE: KRD/HCG PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)) COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A 6MM DIAMETER SPLENIC ARTERY ANEURYSM, THE 9MM X 35CM DELTAFILL18 (DLF180935/S13318) THERMO-MECHANICAL COIL WAS INSERTED BUT THE SIZE DID NOT FIT; THEREFORE, IT WAS REMOVED BUT THE SHEATH BECAME DAMAGED. THE PROGREAT (TERUMO) MICROCATHETER WAS REPLACED WITH A DIFFERENT SIZE MICROCATHETER AND A COMPETITOR COIL WAS IMPLANTED IN THE ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO AND FOLLOWING THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A CHIKAI12 (ASAHI INTECC) GUIDEWIRE, A 4F CONTRAST CATHETER, A PROGREAT (TERUMO) MICROCATHETER, AN ENPOWER CONTROL CABLE (ECB000182-00/S14342), AND A DCB2 DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. AN ISOLATION OF THE FEEDER AND THE DRAINER WAS MADE. THE APPROACH WAS MADE VIA THE RIGHT FEMORAL ARTERY WITH THE CONTRAST CATHETER, MICROCATHETER, AND THE GUIDEWIRE. THE SECOND PHYSICIAN PREPPED THE PRODUCTS AND THE FIRST PHYSICIAN DELIVERED THE COILS. THE FIRST TWO COILS (AZUR) WERE ¿STUCK IN A LOW¿ AND WERE REPLACED WITH THE COMPLAINT COIL. NO FURTHER INFORMATION WAS PROVIDED. THE DELTAFILL18 DEVICE WAS RETURNED WITH THE EMBOLIC COIL ATTACHED AND ADVANCED OUTSIDE THE INTRODUCER. THE DEVICE POSITIONING UNIT (DPU) CORE WIRE WAS SEEN OUTSIDE OF THE INTRODUCER FOR A SIGNIFICANT LENGTH. MULTIPLE KINKS WERE OBSERVED IN THE DPU AT APPROXIMATELY 6 CM, 11 CM, 24 CM, 60 CM, AND 102 CM FROM THE PROXIMAL END OF THE DEVICE. THE BALL TIP OF THE EMBOLIC COIL WAS PRESENT AND INTACT. KINKS WERE OBSERVED ON THE EMBOLIC COIL. THE DISTAL OUTER SHEATH WAS OBSERVED TO BE STRAIGHT, INDICATING THAT THE RESISTANCE HEATING (RH) COIL HAD NOT BEEN HEATED. DAMAGE WAS OBSERVED TO THE DPU CORE WIRE JUST PROXIMAL TO THE MARKER BAND. THE DPU CORE WIRE WAS SEEN EXITING THE RESHEATHING TOOL OUTSIDE THE INTRODUCER. THE DPU CORE WIRE ENTERED THE INTRODUCER AT THE DISTAL END OF THE SKIVE. BLOOD WAS SEEN IN THE INTRODUCER AT THE AREA WHERE THE DPU CORE WIRE RE-ENTERED. DAMAGE WAS ALSO SEEN AT THE DISTAL END OF THE SKIVE. THE V-NOTCH OF THE RESHEATHING TOOL WAS OBSERVED TO BE UNDAMAGED. THE DEVICE COULD NOT BE RE-SHEATHED DUE TO DAMAGE TO THE INTRODUCER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE COMPLAINT THAT THE INTRODUCER WAS DAMAGED WAS CONFIRMED. THE DPU CORE WIRE WAS SEEN PROTRUDING FROM THE INTRODUCER. BECAUSE THE DPU CORE WIRE HAD PROTRUDED FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH DISTAL TO THE RESHEATHING TOOL, THE DEVICE COULD NOT BE RE-SHEATHED. THERE WAS SOME DAMAGE TO THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH NEAR ITS DISTAL END. PROTRUSION OF THE DPU CORE WIRE FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH MAY HAVE OCCURRED DURING ADVANCEMENT OR RETRACTION OF THE EMBOLIC COIL. THE DAMAGE TO THE SKIVE MAY HAVE OCCURRED IF THE RESHEATHING TOOL WAS ADVANCED ALL THE WAY TO THE GREEN INTRODUCER DURING UNSHEATHING. THE IFU INSTRUCTS THE USER TO LEAVE APPROXIMATELY 1 INCH OF THE TRANSLUCENT INTRODUCER SHEATH VISIBLE ON THE DISTAL SIDE OF THE RESHEATHING TOOL WHILE UNSHEATHING THE DEVICE. ADVANCING THE RESHEATHING TOOL FURTHER THAN THIS WILL PUT STRAIN ON THE DISTAL END OF THE SKIVE. THIS MAY CAUSE THE SKIVE TO REMAIN OPEN WHEN ATTEMPTING TO RE-SHEATHE THE DEVICE AND NOT RE-FORM AROUND THE DPU. AS A RESULT, THE DPU WILL NOT PROPERLY RE-SHEATHE. PROPER UNSHEATHING AND RESHEATHING FUNCTIONALITY IS VERIFIED FOR 100% OF DEVICES WHEN THE INTRODUCER LOCK IS FORMED. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED DAMAGE TO THE INTRODUCER OR WITH THE DPU CORE WIRE PROTRUDING FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH. IN ADDITION, BLOOD IN THE INTRODUCER INDICATES THAT A CONSTANT FLUSH MAY NOT HAVE BEEN MAINTAINED. THE IFU ALSO STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE AND INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. THE DAMAGE TO THE DPU CORE WIRE INDICATES EXCESSIVE FORCE WAS USED ON THE DEVICE. THE EMBOLIC COIL WAS ALSO OBSERVED TO BE DAMAGED AT VARIOUS POINTS THROUGHOUT ITS LENGTH. BECAUSE THE EMBOLIC COIL WAS RETURNED ADVANCED OUT FROM THE INTRODUCER AND THE AMOUNT OF INFORMATION GIVEN IN THE COMPLAINT DESCRIPTION, IT IS NOT POSSIBLE TO KNOW THE EXACT CAUSE OF DAMAGE. 100% OF UNITS ARE INSPECTED FOR EMBOLIC COIL DAMAGE DURING MANUFACTURING. IT IS UNLIKELY THAT THE PRODUCT LEFT MANUFACTURING WITH THE OBSERVED DAMAGE. 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 PROCEDURAL AND 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, MAY HAVE 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. 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 6MM DIAMETER SPLENIC ARTERY ANEURYSM, THE 9MM X 35CM DELTAFILL18 (DLF180935/S13318) THERMO-MECHANICAL COIL WAS INSERTED BUT THE SIZE DID NOT FIT; THEREFORE, IT WAS REMOVED BUT THE SHEATH BECAME DAMAGED. THE PROGREAT (TERUMO) MICROCATHETER WAS REPLACED WITH A DIFFERENT SIZE MICROCATHETER AND A COMPETITOR COIL WAS IMPLANTED IN THE ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO AND FOLLOWING THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A CHIKAI12 (ASAHI INTECC) GUIDEWIRE, A 4F CONTRAST CATHETER, A PROGREAT (TERUMO) MICROCATHETER, AN ENPOWER CONTROL CABLE (ECB000182-00/S14342), AND A DCB2 DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. AN ISOLATION OF THE FEEDER AND THE DRAINER WAS MADE. THE APPROACH WAS MADE VIA THE RIGHT FEMORAL ARTERY WITH THE CONTRAST CATHETER, MICROCATHETER, AND THE GUIDEWIRE. THE SECOND PHYSICIAN PREPPED THE PRODUCTS AND THE FIRST PHYSICIAN DELIVERED THE COILS. THE FIRST TWO COILS (AZUR) WERE ¿STUCK IN A LOW¿ AND WERE REPLACED WITH THE COMPLAINT COIL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725081 DELTAFILL18 9MM X 35CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 S13318 10886704077237

    Patients

    Seq Age Sex Outcome Treatment
    1