BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 5606292 · Received April 25, 2016

    Report

    Report Number
    2024168-2016-02626
    Event Type
    Injury
    Date Received
    April 25, 2016
    Date of Event
    March 28, 2016
    Report Date
    April 25, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. ON (B)(6) 2016 (12:57): TROPONIN I=0.00 NG/ML, UPPER REFERENCE LIMIT 0.5. POST-PROCEDURE: ON (B)(6) 2016 (14:45): ECG=NO MYOCARDIAL INFARCTION. ON (B)(6) 2016 (22:02): CK=66 U/L, NORMAL UPPER LIMIT 234. ON (B)(6) 2016 (22:02): CK-MB=2.3 NG/ML, NORMAL UPPER LIMIT 6.3. ON (B)(6) 2016 (09:44): CK=54 U/L, NORMAL UPPER LIMIT 234. ON (B)(6) 2016 (09:44): CK-MB=2.1 NG/ML, NORMAL UPPER LIMIT 6. (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECT OF INTIMAL DISSECTION IS LISTED IN THE NC TREK RX, GLOBAL, INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, A 3.0X15MM NC TREK DILATATION CATHETER PERFORMED PRE-DILATATION ON A MID-LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, 70% STENOSED LESION. FOLLOWING, A DISSECTION WAS NOTED, TREATED WITH THE PLANNED 3.0X18MM XIENCE ALPINE STENT. THE DISSECTION RESOLVED WITHOUT SEQUELA. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED HOME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260047 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50704G1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention