BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAXSFT10 2MM X 6CM

    MDR report key: 8897346 · Received August 15, 2019

    Report

    Report Number
    3008114965-2019-01140
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    June 10, 2019
    Report Date
    June 11, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    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

    PRODUCT COMPLAINT #: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT 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. THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2019-01142. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION FOR A PERIPHERAL ARTERIAL MALFORMATION AT THE SUPRADUODENAL ARTERY, A 2MM X 6CM DELTAXSFT10 (DLX100206, S13463) COULD NOT BE INSERTED AND BECAME ¿STUCK¿ IN THE SHEATH¿S HUB. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER 2MM X 6CM DELTAXSFT10 (DLX100206, S13463) AND THE SAME ISSUE OCCURRED. THEREFORE, THIS DEVICE WAS REPLACED WITH A DIFFERENT SIZE COIL (2MM X 4MM DELTAXSFT). THREE MORE COILS WERE IMPLANTED WITH NO ISSUES AT THE TARGET LESION 3MM X 4MM DELTAXSF, 4MM X 8MM FRAME-C AND 3MM X 12MM DELTAFILL18. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. INITIALLY TWO COILS (1.5MM X 2MM AND 2MM X 4MM DELTAXSFT) WERE IMPLANTED IN THE TARGET LESION. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. NO KINK OR BEND WERE CONFIRMED PRIOR TO USE OF THE DEVICES. NO ADDITIONAL INFORMATION IS AVAILABLE. ONE NON-STERILE DELTAXSFT10 2MM X 6CM WAS RECEIVED INSIDE OF A POUCH. THE HUB WAS INSPECTED, AND IT WAS FOUND WITH NO DAMAGES ON IT. THE DPU WAS INSPECTED AND IT WAS FOUND IN GOOD NORMAL CONDITIONS. THE INTRODUCER WAS INSPECTED, AND IT WAS FOUND ZIPPED, IN GOOD CONDITIONS. THE RE-SHEATING TOOL WAS INSPECTED AND IT WAS FOUND WITH NO DAMAGES ON IT. ALSO, THE MARKER BAND WAS FOUND AT 41CM FROM DISTAL END AND IT WAS FOUND WITHIN SPECIFICATION. THE V-NOTCH WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND IN GOOD CONDITIONS. THE RH WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND WITH NO DAMAGES ON IT, ALSO IT WAS FOUND TO NOT BEING HEATED. THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND PROTRUDED FROM THE INTRODUCER AND IT WAS FOUND STRETCHED. THE FUNCTIONAL TEST COULD NOT ABLE TO PERFORM DUE THE STRETCHED/PROTRUDED CONDITION NOTED ON THE EMBOLIC COIL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE S13463 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED THE COMPLAINT REPORTED BY THE CUSTOMER ¿COIL - IMPEDED-IN INTRODUCER¿ WAS CONFIRMED DUE IN THE FUNCTIONAL ANALYSIS THE EMBOLIC CANNOT PASS THROUGH THE INTRODUCER. THE STRETCHED CONDITION NOTED ON THE EMBOLIC COIL MAY HAVE CONTRIBUTED TO THE FAILURE AND APPEAR TO HAVE BEEN CAUSED BY EXCESSIVE FORCE AND HANDLING BEING APPLIED TO THE DEVICE HOWEVER NONE OF THOSE CAN BE CONCLUSIVELY DETERMINED. NEITHER THE DEVICE HISTORY RECORD REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IMPEDED IN INTRODUCER IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS SEVERAL CAUTIONS RELATING TO THIS SITUATION, INCLUDING INSTRUCTIONS FOR TROUBLESHOOTING THE SITUATION SHOULD IT BE ENCOUNTERED DURING USE. 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 EVENT WAS 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 COIL EMBOLIZATION FOR A PERIPHERAL ARTERIAL MALFORMATION AT THE SUPRADUODENAL ARTERY, A 2MM X 6CM DELTAXSFT10 (DLX100206, S13463) COULD NOT BE INSERTED AND BECAME ¿STUCK¿ IN THE SHEATH¿S HUB. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER 2MM X 6CM DELTAXSFT10 (DLX100206, S13463) AND THE SAME ISSUE OCCURRED. THEREFORE, THIS DEVICE WAS REPLACED WITH A DIFFERENT SIZE COIL (2MM X 4MM DELTAXSFT). THREE MORE COILS WERE IMPLANTED WITH NO ISSUES AT THE TARGET LESION 3MM X 4MM DELTAXSF, 4MM X 8MM FRAME-C AND 3MM X 12MM DELTAFILL18. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. INITIALLY TWO COILS (1.5MM X 2MM AND 2MM X 4MM DELTAXSFT) WERE IMPLANTED IN THE TARGET LESION. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. NO KINK OR BEND WERE CONFIRMED PRIOR TO USE OF THE DEVICES. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE, THE EMBOLIC COIL (DLX100206, S13463) WAS FOUND STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691171 DELTAXSFT10 2MM X 6CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL S13463 10886704077336

    Patients

    Seq Age Sex Outcome Treatment
    1