BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1962627 · Received January 18, 2011

    Report

    Report Number
    1058196-2011-00036
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15186836 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE ORBIT MINI COMPLEX FILL 3X6 COIL ((B)(4)) PREMATURELY DEPLOYED DURING FLUSHING. DURING PREP, A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE DCS SYRINGE. NO DAMAGES WERE NOTED DURING PREP. THE SYRINGE WAS TAKING TO THE BLUE ZONE, AND DURING PREP, THE BLUE ZONE WAS VERY SLIGHTLY EXCEEDED. THE INSTRUCTIONS FOR USE (IFU) CAUTIONS: DO NOT EXCEED THE RED LINE BEYOND POSITION #1 (BLUE ZONE) DURING ANY PART OF THE PURGING OPERATION. EXCESS PRESSURE DURING PREPARATION COULD LEAD TO THE DETACHMENT OF THE EMBOLIC COIL DURING THE PURGING OPERATION. IF THE RED LINE BEYOND POSITION #1 IS EXCEEDED AT ANY POINT DURING PREPARATION, THE DETACHABLE COIL UNIT SHOULD BE VISUALLY INSPECTED TO CONFIRM THE COIL ATTACHMENT. THE SYRINGE HAD BEEN PRESSURIZED ABOVE THE GREEN DETACHMENT ZONE OR ALTERNATIVE DETACHMENT ZONE (RED ZONE) PRIOR TO THE EVENT. THE IFU CAUTIONS THAT IF POSITION #3 (GREEN ZONE) HAS BEEN EXCEEDED THE SYRINGE SHOULD NOT BE USED FOR ADDITIONAL COIL DETACHMENTS. THE SAME SYRINGE WAS USED WITH SUBSEQUENT COILS TO COMPLETE THE PROCEDURE. NO DAMAGES WERE NOTED ON THE ORBIT SYSTEM OR THE SYRINGE. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. (B)(4). THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS ((B)(4)). WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE REPORTED PREMATURE DETACHMENT OF THE COIL DURING PREP. HOWEVER, BASED ON THE REPORTED INFORMATION, THERE ARE IDENTIFIED CONTRIBUTING PROCEDURAL FACTORS ADDRESSED IN THE IFU. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE ORBIT MINI COMPLEX FILL 3X6 COIL (637MF0306) WAS PRE-DEPLOYED DURING FLUSHING. DURING PREP, A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL AND PREP THE SYRINGE. A DCS SYRINGE WAS UTILIZED TO PREP THE DEVICE, AND NO DAMAGES WERE NOTED DURING PREP. THE SYRINGE WAS TAKEN TO THE BLUE ZONE, AND DURING PREP, THE BLUE ZONE WAS SLIGHTLY EXCEEDED. THE SYRINGE WAS A CORDIS/CODMAN PRODUCT THAT WAS UTILIZED TO COMPLETE THE PROCEDURE. PRIOR TO THIS COIL, THE SYRINGE WAS TAKEN PASSED THE GREEN ZONE #3 OR ALTERNATE DETACHMENT ZONE (RED), AND NO LEAKS OCCURRED WITH THE HUB OR ANY SECTION OF THE SYRINGE. THE SYRINGE IS NOT GOING TO BE RETURNED FOR ANALYSIS, BUT A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE. BESIDES THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH DELIVERY SYSTEMS (BROKEN, FRACTURE, ETC) OR COILS (KINK, BEND, STRETCHED, UNRAVELED, BROKEN, FRACTURE, ETC), BUT THE COIL IS NOT GOING TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15186836

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE