BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1170723 · Received September 15, 2008

    Report

    Report Number
    1058196-2008-00221
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS A MALE. THERE WAS NO CALCIFICATION OR TORTUOSITY. ADDITIONAL INFORMATION INDICATED THAT ALL THE DEVICES WERE HANDLE, PREP, AND STORED ACCORDING TO (IFU) INSTRUCTION FOR USE GUIDELINES. ALTHOUGH IT COULD NOT BE CONFIRMED, THERE WAS NO REPORT THAT ANY OF THE PRODUCTS WERE KINKED OR BENT DURING DELIVERY. THERE WAS NO REPORT THAT ANY OF THE PRODUCTS WERE DAMAGED AFER REMOVAL FROM THE PATIENT. IT IS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC. THERE WAS NO REPORT THAT THE ANATOMY WAS DIFFICULT TO ACCESS. NO FURTHER INFORMATION WAS AVAILABLE. ONE NON-STERILE TRUFILL DCS ORBIT AND ONE NON-STERILE MICROCATHETER (PROWLER SELECT PLUS) WERE RECEIVED COILED INSIDE OF A PLASTIC BAG. KINKS WERE NOTED ON THE HYPOTUBE. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGES. THE SUPPORT COIL AND THE EMBOLIC COIL WERE INSIDE OF THE INTRODUCER; THE EMBOLIC COIL STILL ATTACHED TO THE GRIPPER. RESIDUES OF DRIED-BLOOD WERE OBSERVED INSIDE OF THE INTRODUCER. THE OD OF THE TRUFILL DCS ORBIT WAS WITHIN SPECIFICATION. MICROSCOPIC INSPECTION OF THE EMBOLIC COIL WAS PERFORMED OF THE COIL INSIDE OF THE INTRODUCER DUE TO THE FACT THAT IT COULD NOT BE REMOVED. STRETCHED SECTIONS WERE OBSERVED ON THE COIL. THE MC WAS RECEIVED WITH A Y-CONNECTOR ON THE HUB AND COMPRESSED TWISTED SECTIONS WERE FOUND ON THE SHAFT. THE ID OF THE MC WAS WITHIN SPECIFICATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE TRUFIL ORBIT LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13385372 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESS THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IT WAS REPORTED THAT AFTER INABILITY TO INSERT THE ORBIT COIL THROUGH THE PROWLER SELECT MICROCATHETER (MC), THE NEXT COIL WAS SUCCESSFULLY INSERTED; THEREFORE, IT CAN BE CONCLUDED THAT THERE ARE NO MANUFACTURING ISSUES RELATED TO THE MC. BASED ON THE RESIDUAL BLOOD FOUND WITHIN THE RETURNED MICROCATHETER AND THE INABILITY TO CONFIRM WHETHER A CONTINUOUS FLUSH WAS MAINTAINED, DURING THE COIL EMBOLIZATION IN THE ILIAC ARTERY, IT IS POSSIBLE THAT PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. THE INSTRUCTIONS FOR USE (IFU) FOR THE TRUFILL DCS ORBIT OUTLINES THAT IT IS CRITICAL THAT A CONTINUOUS INFUSION OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN THE MICROCATHETER AND THE COIL SYSTEM. BASED ON THE ANALYSIS OF THE RETURNED PRODUCTS, THERE IS NO INDICATION THAT THE REPORTED FAILURE IS RELATED TO THE MANUFACTURING PROCESS. ALTHOUGH NO CONCLUSION CAN BE MADE, IT APPEARS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION IN THE ILIAC ARTERY, LARGE RESISTANCE WAS FELT BETWEEN THE TRUFILL DCS ORBIT 10X30 COMPLEX STANDARD COIL DELIVERY SYSTEM AND THE PROWLER SELECT PLUS MICROCATHETER (MC). THE RESISTANCE WAS FELT WHEN THE COIL WAS ADVANCED TO THE POINT WHERE THE MC WAS NOT INSIDE GC. THIS COIL WAS REMOVED AND ANOTHER COIL (DCS ORBIT, 9X25, FILL) WAS USED TO CONTINUE THE PROCEDURE, WITHOUT ANY FRICTION OR DIFFICULTY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS IN STABLE CONDITION. BECAUSE THE RETURNED COIL WAS STRETCHED AND IT COULD NOT BE CONFIRMED WHEN IN RELATIONSHIP TO THE PROCEDURE, THIS OCCURRED, IT HAS BEEN CAPTURED AS A COMPLAINT.

    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 13385372

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR LOT 13303858