BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3898410 · Received June 26, 2014

    Report

    Report Number
    2024168-2014-04149
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    February 21, 2014
    Report Date
    June 6, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LAB TESTS: (B)(6) 2014 (20:04): CK-MB=0.5 NG/ML, NORMAL UPPER LIMIT 5.0; (B)(6) 2014 (07:41): TROPONIN I=0.02 NG/ML, UPPER REFERENCE LIMIT 0.10; (B)(6) 2014 (18:36): TROPONIN I=0.02 NG/ML, UPPER REFERENCE LIMIT 0.10; (B)(6) 2014: CK=52 U/L, NORMAL UPPER LIMIT 308; (B)(6) 2014: CK-MB=1.5 NG/ML, NORMAL UPPER LIMIT 5.0; (B)(6) 2014: TROPONIN I=23 NG/ML, UPPER REFERENCE LIMIT 0.10; (B)(6) 2014: ELECTROCARDIOGRAM(ECG)=NO MYOCARDIAL INFARCTION; (B)(6) 2014 (06:38)CK=56 U/L, NORMAL UPPER LIMIT 308; (B)(6) 2014 (06:38): CK-MB=1.6 NG/ML, NORMAL UPPER LIMIT 5.0; (B)(6) 2014 (06:38): TROPONIN I=0.23 NG/ML, UPPER REFERENCE LIMIT 0.10. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED DISSECTION IS LISTED IN THE INSTRUCTIONS FOR USE (IFU), IN THE ADVERSE EFFECTS SECTION AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3.0X20MM TREK DILATATION CATHETER PRE-DILATED THE MID-RIGHT CORONARY ARTERY (RCA) LESION. POST PRE-DILATATION, A DISSECTION WAS NOTED THAT RESOLVED ON ITS OWN WITHOUT SEQUELA AND PLANNED INTERVENTION WAS PERFORMED. POST PROCEDURE, THE PATIENTS TROPONIN WAS ELEVATED. THERE WAS NO TREATMENT PROVIDED AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY AS ONSET. THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373386 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30521G1

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other