BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ 7MMX16CM SR PLAT

    MDR report key: 8104091 · Received November 26, 2018

    Report

    Report Number
    3008114965-2018-00814
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    August 24, 2018
    Report Date
    August 24, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    00878528007883
    PMA / PMN Number
    K080379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO.: (B)(4). PROCODE IS KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DELTAPAQ 10 STRETCH RESISTANT COIL 7MM X 16CM (DFS10071620 / P10306) WAS DEFECTIVE DURING THE PROCEDURE. THE DELTAPAQ COIL WAS REPLACED AND THE PATIENT WAS TREATED WITH THE REPLACEMENT COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. THE COMPLAINT PRODUCT WAS RETURNED WITH NO ORIGINAL PACKAGING/LABEL. THE DEVICE WAS RETURNED PARTIALLY UNZIPPED AS INDICATED BY THE LENGTH OF THE INTRODUCER PROXIMAL TO THE RESHEATHING TOOL. THE DEVICE POSITIONING UNIT (DPU) CORE WIRE AND EMBOLIC COIL WAS SEEN PROTRUDING FROM THE SKIVE OF THE INTRODUCER. THE DISTAL END OF THE EMBOLIC COIL WAS SEEN IN THE TRANSLUCENT INTRODUCER. THE DPU CORE WIRE WAS SEEN KINKED AT APPROXIMATELY 6 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 EMBOLIC COIL WAS OBSERVED TO BE STRETCHED WHILE IN THE INTRODUCER. THE EMBOLIC COIL WAS SEEN KINKED AND PROTRUDING FROM AND RE-ENTERING THE SKIVE OF THE INTRODUCER. THE COIL THEN PROTRUDED AGAIN FROM THE INTRODUCER WHERE IT WAS SEEN STRETCHED AND STILL CONNECTED TO THE DPU. THE CONNECTION BETWEEN THE SOCKET RING AND DPU WAS SEEN INTACT. THE DISTAL OUTER SHEATH WAS SEEN NOT SOFTENED INDICATING THAT THE DETACHMENT PROCESS HAD NOT BEEN INITIATED. NO KINKS WERE SEEN ON THE DPU CORE WIRE WHERE IT WAS PROTRUDING FROM THE SKIVE OF THE INTRODUCER. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN DAMAGED WITH A SMALL FRACTURE DOWN ITS CENTER. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT P10306 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT THAT THE DELTAPAQ 10 STRETCH RESISTANT COIL 7MM X 16CM WAS DEFECTIVE IS CONFIRMED. THE EMBOLIC COIL WAS SEEN KINKED, STRETCHED, AND PROTRUDING FROM THE SKIVE OF THE INTRODUCER AT TWO DIFFERENT AREAS. THERE IS NOT ENOUGH INFORMATION IN THE COMPLAINT DESCRIPTION TO DETERMINE THE CAUSE OF THIS FAILURE. HOWEVER, IMPROPER DEVICE UNLOCKING MAY HAVE CONTRIBUTED TO THE FAILURE. BECAUSE THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN DAMAGED, IT INDICATES THAT THE DEVICE WAS NOT PROPERLY UNLOCKED. THE INSTRUCTION FOR USE (IFU) INSTRUCTS THE USER TO UNLOCK THE DEVICE BY GENTLY PULLING THE CLEAR TAB OF THE INTRODUCER SHEATH OUT AND AWAY FROM THE RE-SHEATHING TOOL AT A 45°DEGREE ANGLE. PULLING THE TAB STRAIGHT OUT (IN PARALLEL TO THE DPU) WILL RESULT IN DAMAGE TO THE RESHEATHING TOOL AND MAY CAUSE DAMAGE TO THE EMBOLIC COIL. 100% OF EMBOLIC COILS ARE INSPECTED IN-PROCESS. IN ADDITION, 100% OF RESHEATHING TOOLS ARE TESTED FOR ZIPPING FUNCTIONALITY. IT IS UNLIKELY THAT THE DEVICE LEFT MANUFACTURING WITH THE OBSERVED DAMAGE. THE REPORTED ISSUE THAT THE DELTAPAQ 10 COIL WAS DEFECTIVE WAS CONFIRMED WITH THE RETURNED DEVICE. WITH THE LIMITED INFORMATION AVAILABLE, THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, IMPROPER DEVICE HANDLING MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE REPORTED FAILURE. THE IFU INCLUDES INSTRUCTION ON PROPER DEVICE HANDLING. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY. THUS, IT IS NOT LIKELY THAT THE DELTAPAQ 10 STRETCH RESISTANT COIL 7MM X 16CM COIL LEFT THE MANUFACTURING FACILITY WITH THE DAMAGES OBSERVED ON THE EMBOLIC COIL. 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. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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 THE DELTAPAQ 10 STRETCH RESISTANT COIL 7MM X 16CM (DFS10071620 / P10306) WAS DEFECTIVE DURING THE PROCEDURE. THE DELTAPAQ COIL WAS REPLACED AND THE PATIENT WAS TREATED WITH THE REPLACEMENT COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942779 DELTAPAQ 7MMX16CM SR PLAT NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10 P10306 00878528007883

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR