BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4586775 · Received March 10, 2015

    Report

    Report Number
    2024168-2015-01302
    Event Type
    Injury
    Date Received
    March 10, 2015
    Date of Event
    December 22, 2014
    Report Date
    February 16, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES (B)(6) 2014 (11:30): CK=101 U/L, NORMAL UPPER LIMIT 308 U/L. (B)(6) 2014 (04:30): CK-MB=3.4 NG/ML, NORMAL UPPER LIMIT 5.0 NG/ML. (B)(6) 2014 (11:30): CK-MB=3.6 NG/ML, NORMAL UPPER LIMIT 5.0 NG/ML. (B)(6) 2014 (04:30): TROPONIN I=0.66 NG/ML, NORMAL UPPER LIMIT 0.10 NG/ML. (B)(6) 2014 (11:30): TROPONIN I=0.78 NG/ML, NORMAL UPPER LIMIT 0.10 NG/ML. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE REPORTED PATIENT EFFECT OF DISSECTION IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE NC TREK INSTRUCTION FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE PROCEDURE, A 2.5 X 8 MM NC TREK DILATATION CATHETER WAS USED FOR PRE-DILATATION. A DISSECTION OCCURRED AND ST ELEVATION WAS NOTED. A 3.0 X 8 MM XIENCE ALPINE STENT AND A 3.0 X 12 MM XIENCE ALPINE STENT WERE IMPLANTED TO TREAT THE DISSECTION. THE PATIENT CONDITION RESOLVED ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165977 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention