BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK

    MDR report key: 3753008 · Received April 11, 2014

    Report

    Report Number
    MW5035631
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ABBOTT
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD LEFT HEART CATH PERFORMED THAT PROGRESSED TO INTERVENTION ON THE OSTIAL RCA. (B)(6) PLACED A 4.0X12X RESOLUTE STENT IN OSTIAL RCA AND THEN POST DILATED WITH 4.5 X 8 TREK NC X 3 UP TO 24 ATM'S. BALLOON CATH WOULD NOT COME OUT AND EVENTUALLY THE DISTAL TIP OF THE BALLOON CATHETER SEPARATED AND A PORTION APPROX 10-15 MM WAS LEFT IN THE OST RCA. PT WAS STABLE DURING THIS EVENT AND ARRANGEMENTS MADE FOR SURGICAL INTERVENTION. DATES OF USE: 20 MINUTES. DIAGNOSIS OR REASON FOR USE: POST DILATATION OF STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220944 NC TREK NC TREK LOX ABBOTT REF 1012454-08 208256A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L CORDIS GUIDE CATHETER 3DRC SH| RESOLUTE INTEGRITY STENT 4.0 X 12MM| RUNTHROUGH NS .014X180 CM WIRE| CORDIS GUIDE CATHETER AL1 SH