BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3230208 · Received July 16, 2013

    Report

    Report Number
    2024168-2013-04467
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULTY DEFLATING COULD NOT BE CONFIRMED ON THE RETURNED UNIT DUE TO THE CONDITION OF THE DEVICE. THE DIFFICULTY REMOVING COULD NOT BE CONFIRMED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES OF THE BALLOON NOT DEFLATING. 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. THE REPORTED PATIENT EFFECT OF ANGINA IS LISTED IN THE RX TREK CORONARY DILATATION CATHETER (CDC) INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EFFECT ASSOCIATED WITH THE USE OF THE DEVICE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF ANGINA, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. 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 LEFT MAIN WITH MILD TORTUOUSITY AND MILD CALCIFICATION. AN UNSPECIFIED STENT WAS IMPLANTED AND THE 3.5 X 15 MM TREK BALLOON WAS USED TO PERFORM POST DILATATION AT 12 ATMOSPHERES. THE BALLOON WAS ABLE TO BE INFLATED, HOWEVER IT WAS NOT POSSIBLE TO DEFLATE THE BALLOON. THE INFLATED TREK BALLOON WAS RETRACTED, DURING WHICH, HIGH RESISTANCE WAS ENCOUNTERED. THE PATIENT EXPERIENCED SLIGHT ANGINA DURING THE PROCEDURE, BUT WAS REPORTED TO BE FINE AFTER RETRACTION OF THE DEVICE. NO ADVERSE PATIENT SEQUELA WAS REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT FILING, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING RETRACTION, RESISTANCE WAS ENCOUNTERED BOTH WITH THE ANATOMY AND WITH THE GUIDING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328855 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21204G1

    Patients

    Seq Age Sex Outcome Treatment
    1