BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1954657 · Received January 10, 2011

    Report

    Report Number
    1058196-2011-00017
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    September 25, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN IMPLANTED TWO (5X10MM) COILS SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A THIRD COIL WHICH WAS A TRUFILL DCS ORBIT MINI COMPLEX FILL 2 X 1.5 COIL TO THE LESION AND WAS NOT SATISFIED WITH THE POSITIONING. THE PHYSICIAN WITHDREW THE COIL A LITTLE TO ADJUST IT BUT WAS BLOCKED IN THE PROWLER 14 MICROCATHETER. THE MICROCATHETER AND THE COIL WERE REMOVED AND THE COIL WAS NOTED TO BE STRETCHED. THE PHYSICIAN THEN USED SAME MICROCATHETER AND CHANGED ANOTHER COIL TO COMPLETE THE SURGERY. ANGIOGRAPHY DEMONSTRATED THAT THE ANEURYSM WAS FILLED WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE ACCESS SITE FOR THE PROCEDURE WAS FEMORAL. THE TARGET LESION WAS AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THERE WAS NO STENOSIS NOTED FOR THE PARENT ARTERY. NO FURTHER PROCEDURAL INFORMATION HAS BEEN OBTAINED IN RESPONSE TO INVESTIGATIVE EFFORTS. THE DEVICE WAS NOT RETURNED 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. REVIEW OF LOT 13427498 INCLUDING COIL ASSY LOTS 13370606 AND 13369711 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IT IS POSSIBLE THAT ANEURYSM SIZE/CHARACTERISTICS AND DEVICE MANIPULATION CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, BASED ON THE LIMITED INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING ROOT CAUSE/CONTRIBUTING FACTORS. WITH REVIEW OF THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN IMPLANTED TWO (5X10MM) COILS SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A THIRD COIL WHICH WAS A TRUFILL DCS ORBIT MINI COMPLEX FILL 2 X 1.5 COIL TO THE LESION AND WAS NOT SATISFIED WITH THE POSITIONING. THE PHYSICIAN WITHDREW THE COIL A LITTLE TO ADJUST IT, BUT WAS BLOCKED IN THE PROWLER 14 MICROCATHETER. THE MICROCATHETER AND THE COIL WERE REMOVED AND THE COIL WAS NOTED TO BE STRETCHED. THE PHYSICIAN THEN USED ANOTHER MICROCATHETER AND ANOTHER COIL TO COMPLETE THE PROCEDURE SUCCESSFULLY. ANGIOGRAPHY DEMONSTRATED THAT THE ANEURYSM WAS FILLED WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED. THE ACCESS SITE FOR THE PROCEDURE WAS FEMORAL. THE TARGET LESION WAS AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THERE WAS NO STENOSIS NOTED FOR THE PARENT ARTERY. A 5 FR GUIDING CATHETER AND AN EV3 MICROWIRE WERE USED FOR THE PROCEDURE.

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION WAS MODIFIED AFTER REVIEW TO STATE THAT THE SAME MICRO-CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY AFTER THE REPORTED PRODUCT ISSUE. THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN IMPLANTED TWO (5*10MM) COILS SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A THIRD COIL WHICH WAS A TRUFILL DCS ORBIT MINI COMPLEX FILL 2 X 1.5 COIL TO THE LESION AND WAS NOT SATISFIED WITH THE POSITIONING. THE PHYSICIAN WITHDREW THE COIL A LITTLE TO ADJUST IT BUT WAS BLOCKED IN THE PROWLER 14 MICROCATHETER. THE MICROCATHETER AND THE COIL WERE REMOVED AND THE COIL WAS NOTED TO BE STRETCHED. THE PHYSICIAN THEN USED THE SAME MICROCATHETER AND ANOTHER COIL TO COMPLETE THE PROCEDURE SUCCESSFULLY. ANGIOGRAPHY DEMONSTRATED THAT THE ANEURYSM WAS FILLED WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED. THE ACCESS SITE FOR THE PROCEDURE WAS FEMORAL. THE TARGET LESION WAS AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THERE WAS NO STENOSIS NOTED FOR THE PARENT ARTERY. A 5 FR. GUIDING CATHETER AND AN EV3 MICROWIRE WERE USED FOR THE PROCEDURE.

    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 13427498

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 5 FR. GUIDING CATHETER, EV3 MICROWIRE