BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAXSFT10 2MM X 6CM

    MDR report key: 8162195 · Received December 13, 2018

    Report

    Report Number
    3008114965-2018-00837
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    September 17, 2018
    Report Date
    September 17, 2018
    Manufacturer
    SEE H.10
    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

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). INITIAL REPORTER EMAIL ADDRESS IS NOT REPORTED. (B)(6). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED CEREBRAL ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE FIRST 2MM X 6CM DELTAXSFT 10 COIL (DLX100206 / S13960) WAS REMOVED FROM ITS PACKAGING AND THE PHYSICIAN ATTEMPTED TO INSERT IT INTO THE STRYKER SL-10® MICROCATHETER, BUT THE COIL WAS IMPEDED IN THE MICROCATHETER. THE COIL WAS REPLACED WITH A SECOND 2MM X 6CM DELTAXSFT 10 COIL (DLX100206) FROM THE SAME LOT (S13960). THE SAME ISSUE OCCURRED WITH THIS SECOND COIL WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE COIL INTO THE STRYKER SL-10® MICROCATHETER. THE COIL WAS REPLACED AND THE PROCEDURE CONTINUED TO COMPLETION WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE SECOND 2MM X 6CM DELTAXSFT 10 COIL WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE 2MM X 6CM DELTAXSFT 10 COIL WAS RETURNED IN THE SAME PACKAGE AS THE SECOND COIL FROM THE SAME LOT. THERE WAS NO IDENTIFICATION SEPARATING WHICH WAS THE FIRST COIL AND WHICH WAS THE SECOND COIL DOCUMENTED IN THE COMPLAINT. THE DEVICES WERE MARKED AS UNIT ¿A¿ AND ¿B¿ UPON ANALYSIS IN THE PRODUCT ANALYSIS LAB. UNIT ¿A¿ WAS ASSIGNED TO THIS INVESTIGATION. THE DISTAL END OF THE EMBOLIC COIL WAS SEEN IN THE TRANSLUCENT COIL INTRODUCER. DRIED BLOOD WAS SEEN THROUGHOUT THE INTRODUCER SHEATH. A KINK WAS OBSERVED ON THE DEVICE POSITIONING UNIT (DPU) CORE WIRE AT APPROXIMATELY 41 CM FROM THE PROXIMAL END OF THE DEVICE. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE EMBOLIC COIL DISTAL BALL TIP WAS PRESENT AND INTACT. THE ARTICULATING JOINT AREA AND PROXIMAL END OF THE EMBOLIC COIL COULD BE SEEN SURROUNDED BY BLOOD. KINKS WERE OBSERVED ON THE EMBOLIC COIL. THE EMBOLIC COIL WAS SEEN TWISTED AROUND ITSELF INSIDE THE INTRODUCER SHEATH. THE VIEW OF THE DISTAL OUTER SHEATH WAS DISTORTED FROM THE BLOOD; HOWEVER, THE EMBOLIC COIL WAS SEEN STILL ATTACHED TO THE DPU. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. THE INTRODUCER SKIVE WAS SEEN WIDENED AT THE POINT WHERE THE DPU CORE WIRE PROTRUDED OUT. AN ATTEMPT WAS MADE TO ADVANCE THE DEVICE, BUT THE DPU CORE WIRE AND EMBOLIC COIL COULD NOT MOVE IN THE INTRODUCER DUE TO THE RESISTANCE CAUSED BY BLOOD. THE DEVICE WAS UNABLE TO BE ADVANCED THROUGH A MICROCATHETER DUE TO THE CONDITION IN WHICH IT WAS RETURNED. DURING THE REVIEW OF THE LOT HISTORY RECORDS FOR LOT S13960, IT WAS NOTED THAT 4 UNITS WERE REJECTED DUE TO DAMAGED COILS WHICH IS A CONDITION THAT MAY BE ASSOCIATED WITH THE TYPE OF FAILURE MODE AS REPORTED IN THE COMPLAINT. HOWEVER; THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT ALL PRODUCT REJECTED DURING MANUFACTURING WERE IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. INVESTIGATION CONCLUSION: THE REPORTED ISSUE THAT THE COIL DELIVERY SYSTEM (DCS) WAS IMPEDED IN THE MICROCATHETER WAS NOT CONFIRMED. THE RETURNED DEVICE COULD NOT BE TESTED DUE TO THE CONDITION IN WHICH IT WAS RETURNED. THE DRIED BLOOD IMPEDED THE MOVEMENT OF THE DPU CORE WIRE AND THE EMBOLIC COIL THROUGH THE COIL INTRODUCER. THE STRYKER SL-10® MICROCATHETER THAT WAS USED DURING THE PROCEDURE WAS NOT RETURNED; THEREFORE, A COMPLETE ANALYSIS COULD NOT BE PERFORMED. THE KINKS THAT WERE OBSERVED ON THE EMBOLIC COIL ARE LIKELY CAUSED BY THE APPLICATION OF FORCE AND THE RESISTANCE CAUSED BY THE BLOOD THAT WAS PRESENT. THE BLOOD IN THE COIL INTRODUCER AND SURROUNDING THE EMBOLIC COIL AND ARTICULATING JOINT SUGGESTS THAT THERE WAS SUFFICIENT FLUSH WAS NOT MAINTAINED. THE INSTRUCTION FOR USE (IFU) STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND ALSO INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN RESULT IN RESISTANCE. DEVICES UNDERGO 100% IN-PROCESS INSPECTION. THE KINK OBSERVED ON THE EMBOLIC COIL WOULD HAVE BEEN CAUGHT DURING INSPECTION AT FINAL ASSEMBLY. IT IS UNLIKELY THAT THE 2MM X 6CM DELTAXSFT 10 COIL LEFT THE MANUFACTURING FACILITY WITH THE DAMAGES / KINKS OBSERVED ON THE EMBOLIC COIL. COIL DAMAGE SUCH AS KINKING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE IFU CONTAINS INSTRUCTIONS ON PROPER HANDLING OF THE DEVICE. THE REPORTED ISSUES CAPTURED IN THE COMPLAINT THAT THE COIL DELIVERY SYSTEM (DCS) WAS IMPEDED IN THE MICROCATHETER WAS NOT CONFIRMED THROUGH EVALUATION OF THE RETURNED DEVICE DUE TO THE CONDITION IN WHICH IT WAS RETURNED. BASED ON THE DEVICE HISTORY RECORD REVIEW, IT WAS CONFIRMED THAT ALL PRODUCT REJECTED DURING MANUFACTURING WERE IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE COIL WAS OBSERVED HAVE MULTIPLE KINKS, WHICH IS A REPORTABLE MALFUNCTION, WAS OBSERVED. THE EXACT CAUSE OF THE COIL KINK WAS NOT CONCLUSIVELY DETERMINED, BUT THE LIKELY CAUSE OF THE KINK OBSERVED ON THE EMBOLIC COIL IS APPLIED FORCE. IN ADDITION, IT ALSO APPEARS TO BE RELATED TO AN INSUFFICIENT FLUSH THAT MAY HAVE RESULTED IN RESISTANCE. IT IS ALSO POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE HANDLING, DEVICE MANIPULATION/INTERACTION, ANEURYSM SIZE/VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE OBSERVED ISSUE DURING THE EVALUATION OF THE RETURNED PRODUCT. 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. THIS IS ONE OF TWO (2) WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00836. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED CEREBRAL ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE FIRST 2MM X 6CM DELTAXSFT 10 COIL (DLX100206 / S13960) WAS REMOVED FROM ITS PACKAGING AND THE PHYSICIAN ATTEMPTED TO INSERT IT INTO THE STRYKER SL-10® MICROCATHETER, BUT THE COIL WAS IMPEDED IN THE MICROCATHETER. THE COIL WAS REPLACED WITH A SECOND 2MM X 6CM DELTAXSFT 10 COIL (DLX100206) FROM THE SAME LOT (S13960). THE SAME ISSUE OCCURRED WITH THIS SECOND COIL WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE COIL INTO THE STRYKER SL-10® MICROCATHETER. THE COIL WAS REPLACED, AND THE PROCEDURE CONTINUED TO COMPLETION WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE 2MM X 6CM DELTAXSFT 10 COIL WAS REPORTED AS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999989 DELTAXSFT10 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 S13960 10886704077336

    Patients

    Seq Age Sex Outcome Treatment
    1