BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3092421 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02760
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED DIFFICULTIES WITH REMOVAL COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE DEVICE. 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 THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RENAL ARTERY. AFTER SUCCESSFULLY PREDILATING THE LESION AT 10 ATMOSPHERES WITH THE 5.0X20 MM NC TREK BALLOON, AFTER FULL DEFLATION OF THE BALLOON, THE BALLOON COULD NOT BE RETRIEVED THROUGH THE GUIDING CATHETER. DOUBLE NEGATIVE WAS APPLIED TO THE BALLOON; HOWEVER, IT STILL COULD NOT BE RETRACTED. A GUIDE WIRE WAS PLACED FOR SUPPORT ALONGSIDE THE BALLOON CATHETER AND THE GUIDING CATHETER, BALLOON CATHETER WERE REMOVED AS ONE UNIT, WITHOUT ANY ADVERSE PATIENT EFFECTS. A HERCULINK STENT WAS PLACED SUCCESSFULLY TO COMPLETE THE PROCEDURE. 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
    194833 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30111G1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention