BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2201069 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05674
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE CATHETER NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION. THE HYPOTUBE WAS SEPARATED AT THE DISTAL END OF THE NOSE PIECE, CONFIRMING THE REPORTED SEPARATION. THE FRACTURE FACE WAS OVAL SHAPED AS IF KINKED PRIOR TO SEPARATION. THERE WAS A KINK IN THE STRAIN RELIEF TUBING AT THE DISTAL END OF THE NOSE PIECE. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE CATHETER MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. IT WAS REPORTED THE SHAFT KINKED SLIGHTLY, THEN AN ATTEMPT WAS MADE TO STRAIGHTEN THE SHAFT, WHICH LIKELY CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING. IT SHOULD BE NOTED THE NC TREK INSTRUCTIONS FOR USE STATES: DO NOT USE, OR ATTEMPT TO STRAIGHTEN, A CATHETER IF THE SHAFT HAS BECOME BENT OR KINKED; THIS MAY RESULT IN THE SHAFT BREAKING. INSTEAD, PREPARE A NEW CATHETER. THE ANALYSIS OF THE RETURNED DEVICE DID NOT INDICATE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL RECORDS FOR THE LOT AND A SEARCH OF THE COMPLAINT HANDLING DATABASE INDICATED NO RELATED INCIDENTS, THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, A XIENCE V STENT WAS DEPLOYED SUCCESSFULLY AND POST DILATATION WAS PERFORMED USING A 2.5 X 12 NC TREK BALLOON. DURING REMOVAL OF THE DILATATION CATHETER, NO RESISTANCE WAS FELT; HOWEVER, THE PROXIMAL SHAFT KINKED SLIGHTLY. THE TECHNICIAN ATTEMPTED TO STRAIGHTEN THE KINK AND THE SHAFT SEPARATED AT THE LOCATION OF THE HUB OUTSIDE OF THE ANATOMY. THE CATHETER WAS EASILY REMOVED FROM THE ANATOMY. THE PROCEDURE WAS COMPLETE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1032361

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: XIENCE V