BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3482859 · Received November 21, 2013

    Report

    Report Number
    2024168-2013-07550
    Event Type
    Malfunction
    Date Received
    November 21, 2013
    Date of Event
    October 16, 2013
    Report Date
    October 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. CONCOMITANT PRODUCTS: GUIDE WIRE: BMW U II (REF. # 1009664, LOT # 3073072), GUIDE CATHETER: 6F, EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED RESISTANCE WITH THE GUIDING CATHETER COULD NOT BE REPLICATED AS IT WAS BASED ON CASE CIRCUMSTANCES. THE REPORTED KINKS AND SEPARATION WERE CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY INTERVENTION, THE 2.75X12MM NC TREK BALLOON DILATATION CATHETER ENCOUNTERED RESISTANCE DURING INSERTION INTO THE GUIDE CATHETER AND DURING ADVANCEMENT THROUGH THE GUIDE CATHETER RESULTING IN A SHAFT KINK NEAR THE BALLOON AND A HYPOTUBE SEPARATION. THE DEVICE WAS EASILY REMOVED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE RETURNED DEVICE REVEALED A HYPOTUBE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607747 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30531G1

    Patients

    Seq Age Sex Outcome Treatment
    1