BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODA BALLOON CATHETER

    MDR report key: 1526529 · Received November 10, 2009

    Report

    Report Number
    1820334-2009-00631
    Event Type
    Injury
    Date Received
    November 10, 2009
    Date of Event
    January 31, 2007
    Report Date
    October 15, 2009
    Manufacturer
    COOK INC
    Product Code
    GBZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EACH CODA BALLOON IS SHIPPED WITH AN IFU LISTING WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. SPECIFICALLY, IT WARNS THAT OVER INFLATION MAY RESULT IN DAMAGE AND/OR VESSEL RUPTURE AND THAT THE DEVICE "IS INTENDED FOR TEMPORARY OCCLUSION OF LARGE VESSELS, OR TO EXPAND VASCULAR PROSTHESES." IN THE WARNINGS SECTION, IT IS STATED THAT THE "40MM BALLOON CATHETER SHOULD NOT BE USED IN THE VESSELS LESS THAN 24MM IN DIAMETER." THE INFO THAT WAS RETURNED WAS LIMITED. THE RPN AND LOT NUMBER OF THE DEVICE ARE UNK, MAKING A SEARCH OF OUR MFG RECORDS DIFFICULT. THE COMPLAINT INFO WAS RECEIVED. THE REP INDICATED THAT THE PROCEDURE TOOK PLACE IN 2007 AND THAT A CODA BALLOON WAS BEING USED FOR ANGIOPLASTY OF SEVERE ATHEROSCLEROTIC PLAQUE. WE WERE UNABLE TO CONFIRM THE DATE IN WHICH THE CODA BALLOON WAS USED. THE USE OF THE BALLOON FOR ANGIOPLASTY AND THE DISEASED CONDITION OF THE PT'S ILIAC ARTERY COULD HAVE CONTRIBUTED TO VESSEL DISSECTION. OVER-INFLATION OF THE BALLOON CAN RESULT IN INJURY TO THE VESSEL WALL AND/OR RUPTURE MAY OCCUR. WITH THE INFO PROVIDED AND DESCRIPTION OF THE EVENT IT IS DIFFICULT TO DETERMINE A ROOT CAUSE. THE INTENDED USE OF THE DEVICE AND THE APPROPRIATE WARNINGS ARE DOCUMENTED IN THE SUPPLIED IFU. WE WILL NOTIFY THE APPROPRIATE PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A MALE PT UNDERWENT AAA REPAIR IN 2007. THE PT RECEIVED ANOTHER MFR'S ENDOGRAFTS. DURING THE PROCEDURE, SHEATH INSERTION (ANOTHER MFR'S) AND ANGIOPLASTY, WITH A COOK CODA BALLOON, CAUSED DISLODGEMENT OF UNDERLYING SEVERE ATHEROSCLEROTIC PLAQUE, CAUSING DISSECTION IN THE RIGHT COMMON AND EXTERNAL ILIAC VESSELS. THE DISSECTION WAS REPAIRED USING BALLOON EXPANDABLE STENTS (ANOTHER MFR'S). THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODA BALLOON CATHETER GBZ CATHETER, CHOLANGIOGRAPHY GBZ COOK INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention