BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3193405 · Received June 27, 2013

    Report

    Report Number
    2024168-2013-04027
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 5, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. THE 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. THE REPORTED DEFLATION DIFFICULTY WAS CONFIRMED. BASED ON VISUAL, DIMENSIONAL 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 THE REPORTED EVENT. 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 TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, MILDLY CALCIFIED, 90% STENOSED, MID RIGHT CORONARY ARTERY. THE 2.5X15 MM TREK RX BALLOON CATHETER WAS USED SUCCESSFULLY FOR PREDILATATION ONE TIME AT 12 ATMOSPHERES AND WAS RETRACTED FROM THE ANATOMY. AN UNKNOWN STENT DELIVERY SYSTEM DID NOT CROSS THE LESION SO THE SAME TREK BALLOON WAS REWRAPPED USING THE PROTECTIVE SHEATH; HOWEVER, THE REWRAP WAS NOT SUCCESSFUL AND ANOTHER BALLOON CATHETER WAS USED FOR PREDILATATION. THE REWRAPPED BALLOON WAS INFLATED OUTSIDE THE PATIENTS BODY AND AFTER INFLATION, THE BALLOON PARTIALLY DEFLATED. 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
    291648 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20906G3

    Patients

    Seq Age Sex Outcome Treatment
    1