BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 3072867 · Received April 23, 2013

    Report

    Report Number
    1058196-2013-00093
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 31, 2013
    Report Date
    March 31, 2013
    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 (B)(4) REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT DEVICE IS EXPECTED TO BE RETURNED; THUS ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING THE DEPLOYMENT OF FIRST TRUFILL ORBIT COIL (637MF3575/ 15370956) IN THE BASILAR TIP ANEURYSM, THERE WAS COIL POSITIONING DIFFICULTY AND THE COIL STRETCHED DURING REPOSITIONING AT THE ANEURYSM SITE. THE COIL AND EXCELSIOR SL10 STRAIGHT MICROCATHETER WERE SAFELY REMOVED FROM THE COIL. THE ENTIRE COIL WAS REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM. ANOTHER SAME SIZE ORBIT TRUFILL COIL WAS THEN USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT WAS DOING GOOD POST-PROCEDURE. IT WAS FURTHER EXPLAINED AS THE COIL DIDN'T FIT INTO THE ANEURYSM WALL AS A FRAME EVEN THOUGH THE PHYSICIAN TRIED SEVERAL TIMES FOR FITTING THE COIL INTO ANEURYSM WALL AS A FRAME. IT WAS FURTHER NOTED THAT THE PHYSICIAN KNOWS EXACTLY ABOUT TRUFILL COIL'S CHARACTERISTIC WHICH IS LIKE A RANDOM LOOP. THE VESSEL CHARACTERISTICS WERE UNKNOWN. THERE WAS NO DAMAGE NOTED SUCH AS SEPARATION OR BREAK TO THE COIL DELIVERY SYSTEM. NO POSSIBILITY OF COIL ENTANGLEMENT WITH PREVIOUS COILS AS THIS DIFFICULTY OCCURRED DURING DEPLOYMENT OF FIRST COIL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED AT ALL TIMES. THERE WAS NO DIFFICULTY WHILE GETTING COIL DELIVERY SYSTEM TO THE TARGET SITE THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE/FRICTION OR ANY OTHER DIFFICULTY WHILE ADVANCING OTHER DEVICES PRIOR TO GETTING COIL TO THE TARGET SITE. THERE WERE NO DAMAGES SUCH AS KINK IN THE MICROCATHETER. ONE NON-STERILE ORBIT MINI COMPLEX FILL 3.5X7.5 SYSTEM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND WITHOUT DAMAGED. THE INTRODUCER WAS NOT RECEIVED FOR EVALUATION. THE SUPPORT AND GRIPPER WERE FOUND WITHOUT DAMAGED. THE EMBOLIC COIL WAS FOUND STRETCHED. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGES WHILE THE EMBOLIC COIL STRETCHED. 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. THE REPORTED POSITIONING DIFFICULTY COULD NOT BE EVALUATED OR DETERMINED BASED ON THE ANALYSIS OF THE RETURNED DEVICE; HOWEVER, IT IS POSSIBLE THAT ANEURYSM CHARACTERISTICS/DEVICE SELECTION MAY HAVE CONTRIBUTED. THE REPORTED STRETCHED COIL WAS CONFIRMED WITH THE ANALYSIS; HOWEVER, A ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THAT THE MANIPULATIONS AND CLINICAL/PROCEDURAL FACTORS RESULTING IN FIXING OF THE COIL DURING REPOSITIONING MAY HAVE CONTRIBUTED. WITH ANALYSIS OF THE RETURNED DEVICE AND THE DEVICE HISTORY RECORDS REVIEW, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE DEPLOYMENT OF FIRST TRUFILL COIL (B)(4), IT WAS REPORTED THAT IT GOT STRETCHED DURING REPOSITIONING AT THE ANEURYSM SITE. IT WAS FURTHER EXPLAINED AS THE COIL DIDN'T FIT INTO THE ANEURYSM WALL AS A FRAME EVEN THOUGH THE PHYSICIAN TRIED SEVERAL TIMES FOR FITTING THE COIL INTO ANEURYSM WALL AS A FRAME. IT WAS FURTHER NOTED THAT THE PHYSICIAN EXACTLY KNOW ABOUT TRUFILL COIL'S CHARACTERISTIC WHICH IS LIKE A RANDOM LOOP. SO, TRUFILL COIL AND MICROCATHETER (EXCELSIOR SL10 STRAIGHT) WERE SAFELY REMOVED FROM THE PATIENT. PHYSICIAN USED ANOTHER SAME SIZE TRUFILL COIL AND THE PROCEDURE WAS SUCCESSFULLY DONE. THE ENTIRE COIL WAS REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY DONE AND PATIENT WAS DOING GOOD POST-PROCEDURE. THE TARGET LESION WAS BASILAR TIP ANEURYSM, BUT VESSEL CHARACTERISTICS WERE UNKNOWN. THERE WAS NO DAMAGE NOTED SUCH AS SEPARATION OR BREAK TO THE COIL DELIVERY SYSTEM. NO POSSIBILITY OF COIL ENTANGLEMENT WITH PREVIOUS COILS AS THIS DIFFICULTY OCCURRED DURING DEPLOYMENT OF FIRST COIL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED AT ALL TIMES. THERE WAS NO DIFFICULTY WHILE GETTING COIL DELIVERY SYSTEM TO THE TARGET SITE THROUGH MC. THERE WAS NO RESISTANCE/FRICTION OR ANY OTHER DIFFICULTY WHILE ADVANCING OTHER DEVICES PRIOR TO GETTING COIL TO THE TARGET SITE. THERE WERE NO DAMAGES SUCH AS KINK IN THE MC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173818 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15370956

    Patients

    Seq Age Sex Outcome Treatment
    1