BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    MDR report key: 2001420 · Received February 25, 2011

    Report

    Report Number
    1058196-2011-00071
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 4, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    DQX
    PMA / PMN Number
    K001033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE, THE AGILITY GUIDEWIRE HAD RESISTANCE/FRICTION, THE DISTAL TIP UNRAVELED/STRETCHED THEN FRACTURED/SEPARATED AND HAD WITHDRAWAL DIFFICULTY. DURING A (MCA) MIDDLE CEREBRAL OCCLUSION, THE AGILITY GUIDEWIRE (SOFT 205CM) GOT STUCK IN PLAQUE AND UPON ATTEMPTING TO REMOVE THE GUIDEWIRE, THE DISTAL TIP STRETCHED AND BROKE INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE DISTAL TIP SEGMENT OF THE AGILITY WIRE WITH A CONCENTRIC RETRIEVER AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS. THE LOT NUMBER WAS NOT AVAILABLE. AFTER IT WAS INSERTED IN THE PATIENT, THERE WAS RESISTANCE FRICTION WITH OTHER CORDIS/CODMAN DEVICES, BUT THE DEVICES CATALOG AND LOT NUMBERS WERE NOT AVAILABLE. PRIOR TO INSERTING THE GUIDEWIRE IN THE PATIENT, THE GUIDEWIRE DISTAL TIP WAS RE-SHAPED IN THE STANDARD MANNER, AND AFTER RE-SHAPING IT WAS NOT DAMAGED. DURING THE PROCEDURE, ADDITIONAL TORQUE WAS NEEDED TO CROSS THE LESION OR POSITIONING OF THE DISTAL TIP, AND THE TORQUE WAS APPLIED WHILE THE DISTAL TIP WAS TRAPPED IN A SMALL BRANCH/PLAQUE. THE GUIDEWIRE DELIVERY, TORQUING AND MANEUVERING WAS PERFORMED WHILE CONDUCTING FLUOROSCOPY AT ALL TIMES. THE PROCEDURE WAS COMPLETED WITH A NEUROSCOUT GUIDEWIRE, AND THE PATIENT RECEIVED TPA DURING THE PROCEDURE. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. NO STERILE LOT NUMBER COULD BE PROVIDED THUS NO DHR COULD BE PERFORMED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINTS COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE. HOWEVER, THERE ARE POSSIBLE PROCEDURAL FACTORS, SPECIFICALLY THE TIP RESHAPING AND ADDITIONAL TORQUE APPLIED THAT MAY HAVE CONTRIBUTED TO THE EVENTS.

    Additional Manufacturer Narrative · 1

    DURING AN (MCA) MIDDLE CEREBRAL OCCLUSION, THE AGILITY GUIDEWIRE (SOFT 205CM) GOT STUCK IN PLAQUE AND UPON ATTEMPTING TO REMOVE THE GUIDEWIRE THE DISTAL TIP STRETCHED AND BROKE INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE DISTAL TIP SEGMENT OF THE AGILITY WIRE WITH A CONCENTRIC RETRIEVER AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS. THE LOT NUMBER FOR THE AGILITY WAS NOT AVAILABLE. AFTER IT WAS INSERTED IN THE PATIENT, THERE WAS RESISTANCE FRICTION WITH OTHER CORDIS/CODMAN DEVICES, BUT THE DEVICE'S CATALOG AND LOT NUMBERS WERE NOT AVAILABLE. PRIOR TO INSERTING THE GUIDEWIRE IN THE PATIENT, THE GUIDEWIRE DISTAL TIP WAS RE-SHAPED IN THE STANDARD MANNER, AND AFTER RE-SHAPING IT WAS NOT DAMAGED. DURING THE PROCEDURE, ADDITIONAL TORQUE WAS NEEDED TO CROSS THE LESION AND POSITION THE DISTAL TIP, ADDITIONALLY TORQUE WAS APPLIED WHILE THE DISTAL TIP WAS TRAPPED IN A SMALL BRANCH/PLAQUE. THE GUIDEWIRE DELIVERY, TORQUING AND MANEUVERING WAS PERFORMED WHILE CONDUCTING FLUOROSCOPY AT ALL TIMES. THE PROCEDURE WAS COMPLETED WITH A NEUROSCOUT GUIDEWIRE, AND THE PATIENT RECEIVED TPA DURING THE PROCEDURE. 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

    DURING AN MCA OCCLUSION, THE AGILITY GUIDEWIRE (SOFT 205CM) GOT STUCK IN PLAQUE AND UPON ATTEMPTING TO REMOVE THE GUIDEWIRE, THE DISTAL TIP STRETCHED AND BROKE INSIDE THE PATIENT, THE PHYSICIAN WAS ABLE TO REMOVE THE DISTAL TIP SEGMENT OF THE AGILITY WIRE WITH A CONCENTRIC RETRIEVER & THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY HYDROPHILIC STEERABLE GUIDEWIRES CES GUIDEWIRES (DQX) DQX CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SNARE DEIVE