BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3021524 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01728
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED DIFFICULTY COULD NOT BE REPLICATED. BASED ON VISUAL AND FUNCTIONAL 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. THE XIENCE V STENTS MENTIONED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RESTENOSIS OF XIENCE V STENTS (MORE THAN 1), DEPLOYED IN THE RIGHT CORONARY ARTERY DURING A PREVIOUS PROCEDURE IN ANOTHER HOSPITAL. TWO NON-ABBOTT STENTS WERE DEPLOYED SUCCESSFULLY TO TREAT THE RESTENOSIS AND THE 4.0X20 MM NC TREK WAS USED TO PERFORM POSTDILATATION OF THE TWO STENTS. AFTER FULL DEFLATION OF THE BALLOON, WITH NO DIFFICULTIES EXPERIENCED DURING DEFLATION, RESISTANCE WAS FELT DURING RETRACTION OF THE BALLOON CATHETER FROM THE DEPLOYED STENTS. THE BALLOON WAS REINFLATED AND DEFLATED SEVERAL TIMES; HOWEVER, THE BALLOON COULD NOT BE RETRACTED. NEGATIVE PRESSURE WAS APPLIED AGAIN AND THE BALLOON WAS ABLE TO BE RETRIEVED TO THE TIP OF THE 6FR GUIDING CATHETER, BUT COULD STILL NOT BE RETRACTED INTO THE GUIDE. INFLATION AND DEFLATION OF THE BALLOON WAS PERFORMED AGAIN, AND THIS TIME THE BALLOON CATHETER WAS ABLE TO BE RETRACTED FROM THE PATIENT. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124543 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2073061

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES