BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2010900 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01521
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. FACTORS WHICH MAY CONTRIBUTE TO DIFFICULTIES VISUALIZING A BALLOON DILATATION CATHETER DURING PRODUCT PLACEMENT IN THE TARGET LESION INCLUDE, BUT ARE NOT LIMITED TO, MISSING MARKER BANDS, PATIENT ANATOMY, PROCEDURAL CONTRAST, AND/OR VISUALIZATION EQUIPMENT. TO ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, MARKER BAND PLACEMENT IS 100% VISUALLY INSPECTED AND MEASURED. CATHETER MARKER BAND PLACEMENT IS LOCATED AT THE ENDS OF THE BALLOON WORKING LENGTH AS THIS IS THE AREA OF THE BALLOON THAT COMES INTO CONTACT WITH THE TARGET LESION DURING INFLATION. WITHOUT THE RETURN OF THE PRODUCT FOR EVALUATION, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE TECHNICIAN WAS NOT PROPERLY TRAINED TO USE THE TREK CATHETER AND DID NOT PREPARE THE DEVICE PRIOR TO USE. IT SHOULD BE NOTED THE TREK INSTRUCTIONS FOR USE (IFU) STATES: THIS DEVICE SHOULD BE USED ONLY BY PHYSICIANS TRAINED IN ANGIOGRAPHY AND PTCA, AND / OR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE IFU ALSO STATES: PRIOR TO USE EXAMINE ALL EQUIPMENT CAREFULLY FOR DEFECTS. EXAMINE THE DILATATION CATHETER FOR BENDS, KINKS, OR OTHER DAMAGE. DO NOT USE ANY DEFECTIVE EQUIPMENT. PREPARE EQUIPMENT TO BE USED FOLLOWING MANUFACTURERS INSTRUCTIONS OR STANDARD PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN, UNTRAINED IN USE OF THE DEVICE, HANDED THE UNK TREK TO THE PHYSICIAN WITHOUT PERFORMING ANY DEVICE PREPARATION. WHEN THE BALLOON WAS ADVANCED AND INFLATED IN THE PULMONARY ARTERY TARGET LESION, THE BALLOON COULD NOT BE VISUALIZED. THE BALLOON WAS DEFLATED AND REMOVED. A SECOND UNK TREK WAS HANDED TO THE PHYSICIAN WITH NO DEVICE PREPARATION. ON INFLATION OF THIS BALLOON, AIR BUBBLES WERE OBSERVED IN THE BALLOON MIXED IN WITH THE CONTRAST. THE BALLOON WAS REPORTED TO BE INTACT AND WORKING PROPERLY. THE DEVICE WAS REMOVED AND A THIRD UNK TREK, CORRECTLY PREPARED BY A DIFFERENT, TRAINED TECHNICIAN, WAS SUCCESSFULLY VISUALIZED AND INFLATED IN THE LESION WITHOUT DIFFICULTY. THERE WAS REPORTEDLY NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1