BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAXSFT10 2MM X 6CM

    MDR report key: 7982508 · Received October 18, 2018

    Report

    Report Number
    3008114965-2018-00771
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    July 20, 2018
    Report Date
    July 20, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704077336
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE SIGNIFICANT EMBOLIC COIL DAMAGE NOTED DURING THE PRODUCT INVESTIGATION, THE EVENT MEETS THE CRITERIA FOR MDR REPORTING. PROCODE: KRD/HCG. CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). CONCOMITANT MEDICAL PRODUCTS DUE TO CHARACTER LIMITATION: SUPER SHEATH (BOSTON SCIENTIFIC) SHEATH INTRODUCER, 0.014" 200CM CHIKAI BLACK (ASAHI INTECC) GUIDEWIRE, 6F SHUTTLE SHEATH (COOK) GUIDING CATHETER, EXCELSIOR XT-17 (STRYKER) MICROCATHETER, ENPOWER DCB2 DETACHMENT CONTROL BOX. (B)(6). 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 CAROTID-CAVERNOUS FISTULA (CCF) AT THE SUPERIOR OPHTHALMIC VEIN (SOV) AND CAVERNOUS SINUS (CS), THE SHEATH INTRODUCER OF THE 2MM X 6CM DELTAXSFT10 (DLX100206/S13813) THERMO-MECHANICAL COIL WAS INSERTED INTO THE CONCOMITANT Y-CONNECTOR AND THEY WERE FLUSHED; HOWEVER, WHILE THE COIL WAS BEING ADVANCED INTO THE EXCELSIOR XT-17 (STRYKER) MICROCATHETER, THE COIL BECAME STUCK AND WOULD NOT EXIT THE INTRODUCER. THE COIL WAS REPLACED WITH A COIL FROM THE SAME LOT, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PROCEDURE WAS NOT DELAYED DUE TO THE EVENT. THE COMPLAINT 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 DAMAGE WAS NOTED PRIOR TO AND AFTER THE EVENT. A SUPER SHEATH (BOSTON SCIENTIFIC) SHEATH INTRODUCER, 0.014¿ 200CM CHIKAI BLACK (ASAHI INTECC) GUIDEWIRE, 6F SHUTTLE SHEATH (COOK) GUIDING CATHETER, AND AN ENPOWER DCB2 DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. NO FURTHER INFORMATION WAS PROVIDED. TWO DEVICES WITH THE SAME CATALOG NUMBER AND LOT NUMBER WERE RETURNED IN THE SAME PACKAGE FOR THIS COMPLAINT. BOTH DEVICES ON THE COMPLAINT WERE REPORTED TO HAVE THE SAME ISSUE. SINCE THE TWO DEVICES CANNOT BE DISTINGUISHED, THEY WERE ARBITRARILY ASSIGNED TO THE TWO PRODUCT INVESTIGATIONS AND WERE EVALUATED SEPARATELY. DEVICE A: THE INTRODUCER LENGTH PROXIMAL TO THE RESHEATHING TOOL INDICATED THAT THE DEVICE WAS RETURNED PARTIALLY UNSHEATHED. THE DISTAL END OF THE EMBOLIC COIL WAS OBSERVED IN THE TRANSLUCENT INTRODUCER. NO KINKS WERE OBSERVED ON THE DEVICE POSITIONING UNIT (DPU) CORE WIRE OR INTRODUCER. THE DISTAL BALL TIP OF THE EMBOLIC COIL WAS PRESENT AND INTACT. THE PROXIMAL AREA OF THE DEVICE WAS KINKED AND CIRCLED AROUND ITSELF IN A LOOP INSTEAD OF IN-LINE WITH THE INTRODUCER. THE EMBOLIC COIL WAS SEPARATED FROM ITS SOCKET RING PROXIMAL CONNECTOR; HOWEVER, THE BLUE SUTURE AND SOCKET RING WAS STILL CONNECTED TO THE DEVICE POSITIONING UNIT (DPU) CORE WIRE AT THE ARTICULATING JOINT. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. THE ARTICULATING JOINT AREA WAS OBSCURED BY THE INTRODUCER. THE DEVICE WAS UNABLE TO BE ADVANCED OUT FROM THE INTRODUCER TO BETTER OBSERVE THE UNIT. WHEN THE DPU CORE WIRE WAS PUSHED FORWARD, THE EMBOLIC COIL WAS SEEN IMPEDED IN THE INTRODUCER. DURING THE REVIEW OF THE MANUFACTURING DOCUMENTATION, IT WAS NOTED THAT 4 UNITS WERE REJECTED. HOWEVER, THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE REPORTED CUSTOMER COMPLAINT OF IMPEDED IN INTRODUCER WAS CONFIRMED. THE DEVICE COULD NOT BE ADVANCED OUT OF THE INTRODUCER DUE TO THE COIL BEING DAMAGED/KINKED AND ITS MOTION ANGLED AGAINST THE INNER WALLS OF THE INTRODUCER RESULTING IN FRICTION AND IMPEDANCE. THE EMBOLIC COIL WAS DAMAGED, KINKED, AND DETACHED FROM ITS PROXIMAL SOCKET RING. THE EXACT CIRCUMSTANCES SURROUNDING THE OBSERVED DAMAGE TO THE COIL CANNOT BE DETERMINED BASED ON THE CONDITION OF THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT THE DAMAGE OCCURRED DURING INSERTION INTO THE DELIVERY SYSTEM. THE DAMAGE SEEN TO THE EMBOLIC COIL MAY HAVE BEEN A RESULT OF EXCESSIVE FORCE APPLIED WHEN ATTEMPTING TO ADVANCE AND RETRACT THE DEVICE. IMPEDED IN INTRODUCER IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE IFU CONTAINS SEVERAL CAUTIONS RELATING TO THIS SITUATION, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. 100% OF DEVICES ARE INSPECTED FOR DAMAGE TO THE EMBOLIC COIL AND SOCKET RING AREA. IN ADDITION, 100% OF DEVICES ARE TESTED FOR MOVEMENT FUNCTIONALITY OF THE DPU CORE WIRE AND EMBOLIC COIL. THUS, IT IS UNLIKELY THAT THE DEVICE LEFT THE MANUFACTURING FACILITY WITH THE OBSERVED ISSUES. NEITHER THE PRODUCT ANALYSIS NOR THE DEVICE HISTORY RECORD REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE INFORMATION PROVIDED AND THE EVIDENCE PRESENTED BY THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS, INCLUDING DEVICE MANIPULATION AND DEVICE INTERACTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE AND DAMAGES NOTED ON 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00772.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A CAROTID-CAVERNOUS FISTULA (CCF) AT THE SUPERIOR OPHTHALMIC VEIN (SOV) AND CAVERNOUS SINUS (CS), THE SHEATH INTRODUCER OF THE 2MM X 6CM DELTAXSFT10 (DLX100206/S13813) THERMO-MECHANICAL COIL WAS INSERTED INTO THE CONCOMITANT Y-CONNECTOR AND THEY WERE FLUSHED; HOWEVER, WHILE THE COIL WAS BEING ADVANCED INTO THE EXCELSIOR XT-17 (STRYKER) MICROCATHETER, THE COIL BECAME STUCK AND WOULD NOT EXIT THE INTRODUCER. THE COIL WAS REPLACED WITH A COIL FROM THE SAME LOT, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PROCEDURE WAS NOT DELAYED DUE TO THE EVENT. THE COMPLAINT 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 DAMAGE WAS NOTED PRIOR TO AND AFTER THE EVENT. A SUPER SHEATH (BOSTON SCIENTIFIC) SHEATH INTRODUCER, 0.014¿ 200CM CHIKAI BLACK (ASAHI INTECC) GUIDEWIRE, 6F SHUTTLE SHEATH (COOK) GUIDING CATHETER, AND AN ENPOWER DCB2 DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. EVALUATION OF THE RETURNED PRODUCTS REVEALED EMBOLIC COIL DAMAGE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822175 DELTAXSFT10 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 S13813 10886704077336

    Patients

    Seq Age Sex Outcome Treatment
    1