BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3374952 · Received September 30, 2013

    Report

    Report Number
    2024168-2013-06206
    Event Type
    Malfunction
    Date Received
    September 30, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 27, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED DIFFICULTY REMOVING THE BALLOON SHEATH WAS NOT ABLE TO BE CONFIRMED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE CONFIRMED. BASED ON AN EXPANDED INVESTIGATION AND FURTHER REVIEW OF THE COMPLAINT HANDLING DATABASE AND OTHER SOURCES OF NONCONFORMITY DATA, IT WAS DETERMINED THAT THE POSSIBLE CAUSE FOR THE FAILURE MODE WAS A RESULT OF DIFFICULTY IN REMOVING THE BALLOONS PROTECTIVE SHEATH. THE DATA SUGGESTED A POSSIBLE PRODUCT DEFICIENCY, WHICH REQUIRES PROCEDURAL CHANGES TO OPTIMIZE THE PROCESS IN MANUFACTURING. EFFECTIVENESS CHECKS WILL BE PUT IN PLACE MONITOR THE EFFECTIVENESS OF THE IMPLEMENTED CORRECTIVE AND PREVENTATIVE ACTIONS. THE ADDITIONAL TREK DEVICE REFERENCED HAS BEEN FILED UNDER A SEPARATE MEDWATCH REPORT #.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REMOVAL OF THE PROTECTIVE SHEATH FROM THE FIRST 3.5X15 MM TREK BALLOON CATHETER (LOT # 21102G1) BY THE TECH, IT APPEARED THAT THE BALLOON HAD SEPARATED FROM THE CATHETER INSIDE THE SHEATH. IT IS UNCLEAR IF ANY RESISTANCE WAS FELT DURING REMOVAL OF THE SHEATH FROM THE CATHETER. THE DEVICE COULD NOT BE USED ON THE PATIENT. A SECOND 3.5X15 MM TREK BALLOON CATHETER (LOT # 2081561) WAS SELECTED FOR USE; HOWEVER, THE PROTECTIVE SHEATH ON THIS DEVICE COULD NOT BE REMOVED AT ALL BY THE TECH. THE DEVICE WAS HANDED TO THE PHYSICIAN WHO ALSO COULD NOT REMOVE THE SHEATH. SALINE WAS POURED IN AND AROUND THE SHEATH AND THE SHEATH STILL COULD NOT BE REMOVED. THE DEVICE COULD NOT BE USED ON THE PATIENT. ANOTHER 3.5X15 MM TREK BALLOON WAS USED SUCCESSFULLY TO COMPLETE THE CASE. THE MORNING AFTER THE PROCEDURE, THE PROTECTIVE SHEATH WAS ABLE TO BE REMOVED FROM THE BALLOON WITHOUT ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493232 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2081561

    Patients

    Seq Age Sex Outcome Treatment
    1