BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3241216 · Received July 22, 2013

    Report

    Report Number
    2024168-2013-04591
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL NC TREK REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE REPORTED DIFFICULTY TO REMOVE THE PROTECTIVE SHEATH AND DIFFICULTY TO POSITION OVER THE GUIDE WIRE COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. THE OUTER MEMBER AND INNER MEMBER WERE COLLAPSED. THE OUTER MEMBER WAS WRINKLED, AND THERE WAS A KINK IN THE SUPPORT WIRE PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WERE TWO BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING. THE PROTECTIVE SHEATH AND STYLET WERE NOT RETURNED. BASED ON AN EXPANDED INVESTIGATION AND FURTHER REVIEW OF THE COMPLAINT HANDLING DATABASE AND OTHER SOURCES OF NONCONFORMITY DATA, IT WAS DETERMINED THAT THE DEVICE PERFORMANCE WITH REGARDS TO THE DIFFICULTY WITH REMOVING THE PROTECTIVE SHEATH APPEAR TO NOT BE RELATED TO A MANUFACTURING ISSUE, BUT DUE TO NORMAL VARIATION FOUND IN MANUFACTURING, AS THE OCCURRENCE RATES FOR THIS SIZE OF BALLOON ARE WITHIN THE EXPECTED RATE IN THE PRODUCT RISK ASSESSMENT. THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3.75 X 8 MM NC TREK BALLOON CATHETER WAS UN-PACKAGED; HOWEVER, SEVERE RESISTANCE WAS NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH. FORCE WAS NEEDED TO SUCCESSFULLY REMOVE THE SHEATH. WHEN THE NC TREK WAS ADVANCED OVER THE GUIDE WIRE, RESISTANCE WAS NOTED AND THE DEVICE COULD NOT BE ADVANCED. IT WAS NOTED THAT THE NC TREK FELT VERY STICKY. DURING REMOVAL, RESISTANCE WAS ALSO EXPERIENCED WITH THE GUIDE WIRE. A NEW 3.75 X 8 MM NC TREK BALLOON WAS UN-PACKAGED, BUT FORCE WAS NEEDED TO REMOVE THE PROTECTIVE SHEATH AGAIN. RESISTANCE WAS NOTED WITH THE GUIDE WIRE DURING ADVANCEMENT AND REMOVAL, AND THIS NC TREK ALSO WAS NOT USED. A NON-ABBOTT BALLOON CATHETER WAS USED SUCCESSFULLY WITH THE SAME GUIDE WIRE. IT WAS NOTED THAT BOTH NC TREK BALLOON CATHETERS WERE PREPARED PER THE INSTRUCTIONS FOR USE, PRIOR TO ADVANCEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341294 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21005G1

    Patients

    Seq Age Sex Outcome Treatment
    1