BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 4051793 · Received September 2, 2014

    Report

    Report Number
    2024168-2014-05607
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    July 11, 2014
    Report Date
    August 8, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(6) 2014: (16:56)CK=58.0 U/L, NUL 234.0; (B)(6) 2014: (16:56)CENTRAL LAB CK-MB=3.0 NG/ML, NUL 6.0. CONCOMITANT PRODUCTS: DILATATION CATHETER: SPRINTER LEGEND RX 2.0X15. GUIDE CATH: 6FR. 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 OTW 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT A STENTING PROCEDURE TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX ARTERY. PRE-DILATATION WAS PERFORMED USING A 1.2 X 12 MM TREK OTW DILATATION CATHETER AND A 2.0 X 15 NON-ABBOTT DILATATION CATHETER. AFTER PRE-DILATATION WAS PERFORMED, IT WAS NOTED THAT A SMALL DISSECTION HAD OCCURRED; HOWEVER, IT WAS UNKNOWN WHICH DEVICE CAUSED THE DISSECTION. A 2.25 X 23 MM XIENCE XPEDITION STENT AND A 2.25 X 08 MM XIENCE XPEDITION STENT WERE IMPLANTED IN THE PROXIMAL CIRCUMFLEX ARTERY TO TREAT THE DISSECTION AND THE LESION. THE PATIENT CONDITION RESOLVED ON (B)(6) 2014. POST PROCEDURE, THE PATIENT EXPERIENCED A VASOVAGAL RESPONSE, WITH HYPOTENSION AND BRADYCARDIA. MEDICATION WAS ADMINISTERED AND THE PATIENT CONDITION RESOLVED ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532530 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention