BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDER SOFTIP GUIDING CATHETERS

    MDR report key: 1832797 · Received September 13, 2010

    Report

    Report Number
    2939204-2010-00948
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K980453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED IT WAS DETERMINED THAT THE PATIENT'S ANATOMY WAS A BIT TORTUOUS AND RESISTANCE WAS FELT AS THE BALLOON AND STENT WERE PASSING THROUGH THE CAROTID ARTERY. CONTINUOUS FLUSH WAS MAINTAINED WITH A SALINE/HEPARIN SOLUTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. A GUIDE CATHETER WAS RETURNED ALONG WITH AN UNIDENTIFIED STENT CATHETER INSIDE THE LUMEN. MAGNIFIED AND TACTILE INSPECTION OF THE CATHETER REVEALED APPROXIMATELY 2.25 MM OF THE DISTAL END HAD SEPARATED. THE SEPARATED PORTION HAS SCRATCHES. THE PROXIMAL EDGE OF THE SEPARATION WAS FLATTENED WITH SOME BRAIDING EXPOSED. DRIED BLOOD WAS EVIDENT AROUND THE EDGE AND INSIDE THE LUMEN. INSPECTION OF THE TRANSITION OF THE REINFORCED TIP AND NON-REINFORCED TIP SHOWED TWO SURFACES THAT ARE JAGGED. THIS IS TYPICAL OF PROPER POLYMER FLOW BETWEEN THE TWO TUBES WHEN HEAT BONDED TOGETHER AND THEN STRESSED TO FRACTURE. INSPECTION OF THE PINK TO BLUE POLYMER MELT ALSO SHOWS PROPER POLYMER BLEND AFTER REFLOW. A TIP BOND THAT DID NOT SEE ENOUGH HEAT WOULD HAVE EXHIBIT A SMOOTH EDGE NOT SHOWN IN THIS CATHETER. THIS CATHETER ALSO HAD TWO NON-NORMAL CHARACTERISTICS THAT WOULD NOT HAVE PASSED NORMAL PRODUCT INSPECTION. THE FIRST WAS THE TIP APPEARED FLATTENED AT THE BOND SITE. THE SECOND WAS THE SCRATCHED AND INDENTED SURFACE ON THE NON-REINFORCED TIP OUTER SURFACE. BOTH OF THESES CHARACTERISTICS SUGGEST THAT SOME EXTERNAL FORCE WAS EXERTED ON THE TIP CAUSING THE TIP BOND TO FAIL. BASED ON THE AVAILABLE INFORMATION AND PRODUCT RETURN AN EXACT ROOT CAUSE WAS UNABLE TO BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO A SEPARATED TIP INCLUDE HANDLING OF THE DEVICE, PLACEMENT TECHNIQUE, PATIENT ANATOMY, AMOUNT OF SUPPORT PROVIDED DURING THE PROCEDURE, OR DAMAGE TO THE DEVICE DURING MANUFACTURING. AS THERE WAS NO EVIDENCE OF ANY SPECIFICATION NON-CONFORMANCES RELATED TO THE COMPLAINT DEVICE, IT IS LIKELY THAT THE DEVICE MET SPECIFICATION BUT PERFORMANCE WAS LIMITED BY INTERACTION WITH PATIENT ANATOMY, INTERACTION WITH OTHER DEVICES OR OTHER PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE RELATED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    DURING PROCEDURE THE TIP OF THE GUIDE CATHETER BROKE OFF. THE PIECE WAS RETRIEVED WITH THE USE OF THE STENT BALLOON AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

    Description of Event or Problem · 1

    DURING PROCEDURE THE TIP OF THE GUIDE CATHETER BROKE OFF. THE PIECE WAS RETRIEVED WITH THE USE OF THE STENT BALLOON AND THE PROCEDURE WAS SUCESSFULLY COMPLETED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDER SOFTIP GUIDING CATHETERS CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H965100460 12711178

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR TRANSEND GUIDEWIRE (BOSTON SCIENTIFIC)| BALLOON STENT SYSTEM (MODEL AND MANF. UNKNOWN)| EXCEL MICROCATHETER (BOSTON SCIENTIFIC)