BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3133903 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03342
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED DIFFICULTY INFLATING WAS ABLE TO BE CONFIRMED. THE BALLOON WAS TIGHTLY FOLDED; THE SHAFT WAS STRETCHED/NECKED DISTAL TO THE MID LAP SEAL FOR A LENGTH OF 1 MM. FUNCTIONAL TESTING REVEALED THAT THE DIFFICULTY INFLATING WAS DUE TO THE STRETCHED/NECKED SHAFT. THOUGH DIFFICULTY REMOVING THE PROTECTIVE SHEATH WAS NOT REPORTED, BASED ON THE DEVICE VISUAL AND FUNCTIONAL ANALYSIS, THE STRETCHED SHAFT AT THE MID-LAP SEAL APPEARS TO BE RELATED TO DIFFICULTY REMOVING THE PROTECTIVE SHEATH. 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 AND SUBSEQUENT CONSEQUENCES OF DIFFICULTY WITH INFLATION WERE POTENTIALLY RELATED TO A MANUFACTURING ISSUE. CORRECTIVE AND PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE ARE IN THE PROCESS OF BEING IMPLEMENTED AND THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDEWIRE: RUNTHROUGH NC. INFLATION: INDEFLATOR. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MILDLY TORTUOUS, MILDLY CALCIFIED, CONCENTRIC, 90% STENOSED, DE NOVO DISTAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION, THE NON-ABBOTT STENT WAS IMPLANTED AND THE 3.5 X 15 MM NC TREK BALLOON DILATATION CATHETER (BDC) USED FOR POST-DILATATION, HOWEVER, DURING INFLATION WITH AN INDEFLATOR TO 10 ATMOSPHERE (ATM) THE BALLOON DID NOT INFLATE. OUTSIDE THE ANATOMY INFLATION WAS ATTEMPTED BUT THE BALLOON COULD NOT BE INFLATED. A NON-ABBOTT BDC WAS USED ONE OR TWO TIMES SUCCESSFULLY FOR POST-DILATATION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234935 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30205G1

    Patients

    Seq Age Sex Outcome Treatment
    1