BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAXSFT10 2MM X 6CM

    MDR report key: 7063338 · Received November 28, 2017

    Report

    Report Number
    3008114965-2017-00502
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    October 31, 2017
    Report Date
    October 31, 2017
    Product Code
    KRD
    UDI-DI
    10886704077336
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #3008114965-2017-00502. THIS CORRECTION IS BEING SUBMITTED TO CAPTURE THE COMPLAINT DEVICE RETURN. THE PRODUCT HAS BEEN FORWARDED TO CODMAN FOR EVALUATION AND TESTING, HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR THIS REPORT. CONCLUSION: THE DEVICE WAS RETURNED COILED INTO A LARGE CULTURE DISH. THE EMBOLIC COIL IS DETACHED FROM THE DEVICE POSITIONING UNIT (DPU). THE EMBOLIC COIL WAS RETURNED WITH THE DEVICE. THE DEVICE IS FULLY UNSHEATHED, AND THE RESHEATHING TOOL HAS BEEN ADVANCED ALL THE WAY TO THE GREEN INTRODUCER. THE DPU CORE WIRE IS KINKED AT THE STRAIN RELIEF. THERE ARE BENDS IN THE DPU CORE WIRE APPROXIMATELY 45 CM, 107 CM, AND 109 CM FROM THE PROXIMAL END. SUTURE FIBERS ARE VISIBLE AT THE PROXIMAL END OF THE EMBOLIC COIL. THE BALL TIP IS INTACT. THE EMBOLIC COIL IS KINKED. THE RESISTANCE HEATING (RH) COIL HAS HEATED AND MELTED. THE V-NOTCH OF THE RESHEATHING TOOL SHOWS SOME PLASTIC REMODELING. THE RESISTANCE OF THE DEVICE WAS TESTED WITH MULTIMETER. THE RESISTANCE WAS 53.4 ¿, WHICH IS WITHIN THE SPECIFICATION RANGE OF 48.5 ¿ 56 ¿. THE DPU WAS CONNECTED TO THE ENPOWER CONTROL CABLE AND THE DETACHMENT CONTROL BOX DCB2000500 RETURNED ON THE COMPLAINT AND THE POWER WAS TURNED ON. THE SYSTEM READY LIGHT ILLUMINATED. DETACHMENT CANNOT BE TESTED, SINCE THE EMBOLIC COIL IS DETACHED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. A NON-CONFORMANCE WAS GENERATED BECAUSE OUTER DIAMETER (OD) OF THE RESISTANCE HEATING (RH) COIL ASSEMBLY WAS NOT INSPECTED DURING PRODUCT FINAL INSPECTION. HEALTH HAZARD EVALUATION CONCLUDED THAT THE PRIMARY RISK OF THE RH COIL OD BEING OUT OF SPECIFICATION IS THAT THE END USER WOULD EXPERIENCE FRICTION WHILE ADVANCING OR RETRACTING THE DEVICE THROUGH A MICROCATHETER. IN ADDITION, STATISTICAL EVALUATION IN THE HHE INDICATED THAT PRODUCT IN THE FIELD SHOULD BE WITHIN SPECIFICATION, EVEN THOUGH THE REQUIRED INSPECTION WAS NOT CONDUCTED. BASED ON THE RESULTS OF THE HHE PRODUCT WAS RELEASED AS ACCEPTABLE. THERE ARE NO CURRENT SAFETY SIGNALS FOR THIS LOT NUMBER, PRODUCT, OR ISSUE. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE COMPLAINT THAT THE EMBOLIC COIL FAILED TO DETACH IS CONFIRMED BASED ON THE EVIDENCE THAT THE EMBOLIC COIL WAS RETURNED AND THE RH COIL HAS HEATED. THE EVIDENCE THAT THE RH COIL HAS HEATED INDICATES THAT A DETACH CYCLE WAS COMPLETED. HOWEVER, THE RETURN OF THE EMBOLIC COIL INDICATES THAT THE COIL DID NOT DETACH AT THE DELIVERY SITE AND WAS REMOVED WITH THE DPU. THE DETACHMENT FIBER IS NOT VISIBLE AT THE DISTAL END OF THE DPU. WHILE THE RESISTANCE OF THE DEVICE IS WITHIN SPECIFICATION, IT IS POSSIBLE THAT THE KINK IN THE DPU CORE WIRE INHIBITED THE EFFECTIVE HEATING OF THE RH COIL, RESULTING IN INCOMPLETE DETACHMENT. THE KINK AND BENDS IN THE DPU CORE WIRE, ALONG WITH THE KINKED EMBOLIC COIL, ARE INDICATIVE OF APPLICATION OF EXCESSIVE FORCE. EVALUATION OF THE ENPOWER CONTROL CABLE AND DCB2 RETURNED ON THE COMPLAINT INDICATES THAT BOTH OF THOSE DEVICES WERE FUNCTIONING PROPERLY. THERE ARE NO CURRENT SAFETY SIGNALS FOR THIS PRODUCT FAMILY, SPECIFIC PRODUCT, LOT NUMBER, OR ISSUE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: DCB2 (DCB2000500/GS1-128), GUIDEWIRE (SYNCHRO, STRYKER), A GUIDING CATHETER (6F FUBUKI, ASAHI INTECC), A MICROCATHETER (EXCELSIOR SL-10, STRYKER). INITIAL REPORTER INFORMATION UNAVAILABLE. (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAXTRASOFT (DLX100206/S12442) WAS USED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR A PAO AT THE VA WHERE THE COIL COULD NOT BE DETACHED. THE DELTAXTRASOFT (COMPLAINT PRODUCT) COULD NOT BE DETACHED WHEN CONNECTED TO THE ENPOWER CONTROL CABLE (ECB00018200/LOT UNKNOWN). THERE WERE NO ISSUES WHEN THE LIGHT ON THE BOX WAS CHECKED. THE CABLE WAS REPLACED BUT THE ISSUE CONTINUED. THE COIL WAS REPLACED WITH A DIFFERENT COIL. ANOTHER DELTAXTRASOFT (DLX100206/S12442) WAS INSERTED INTO THE MICROCATHETER BUT RESISTANCE WAS FELT AND IT WAS NOT POSSIBLE TO DELIVER THE COIL. THE PHYSICIAN ATTEMPTED TO USE ANOTHER DELTAXTRASOFT BUT THE SAME ISSUE OCCURRED; THEREFORE, A DIFFERENT COIL WAS USED. THERE WERE NO KINKS OR BENDS NOTED TO THE MICROCATHETER. THE PATIENT WAS A (B)(6) MALE WHOSE VESSEL WAS MODERATELY TORTUROUS AND CALCIFICATION WAS UNKNOWN. A DCB2 (DCB2000500/GS1-128), GUIDEWIRE (SYNCHRO, STRYKER), A GUIDING CATHETER (6F FUBUKI, ASAHI INTECC), A MICROCATHETER (EXCELSIOR SL-10, STRYKER) WERE ALSO USED FOR THIS PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY/COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844607 DELTAXSFT10 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD DLX100206 S12442 10886704077336

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR