BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVC INSIGHT CATHETER

    MDR report key: 3412998 · Received October 10, 2013

    Report

    Report Number
    3004722468-2013-00003
    Event Type
    Injury
    Date Received
    October 10, 2013
    Date of Event
    May 30, 2013
    Report Date
    October 10, 2013
    Manufacturer
    INFRAREDX INC.
    Product Code
    OGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED WITH PROGRESSIVE CHEST PAIN FOR STAGED PCI OF PROXIMAL RAMUS BRANCH. UNDERWENT PCI AND DURING PROCEDURE HAD A PLAQUE SHIFT TO THE LAD REQUIRING COMPLICATED BIFURCATION PCI. THIS WAS FURTHER COMPLICATED BY ABRUPT CLOSURE DURING PCI OF LM PUTTING PATIENT IN CARDIOGENIC SHOCK. PATIENT WENT INTO CARDIAC ARREST FOLLOWING INSERTION OF BALLOON CATHETER, TVC INSIGHT CATHETER, REMOVAL OF TVC INSIGHT CATHETER, BALLOON INFLATION (6ATM FOR 7 SECS), AND REMOVAL OF BALLOON CATHETER. THROMBUS DETECTED IN LM. REQUIRED EMERGENT LM STENTING IN AN UNPROTECTED MANNER. IMPELLA PLACED AND PCI RESTORED LEFT CORONARY FLOW. POST PROCEDURE MASSIVE EXSANGUINATION FROM L ACCESS SITE AS GROIN HEMATOMA AND RETROPERITONEAL BLEED NOTED. UNDERWENT EMERGENT VASCULAR REPAIR OF L FEMORAL ARTERY. POST IMPELLA REMOVAL, R LEG BECAME COMPROMISED REQUIRING SURGICAL REPAIR AND THROMBECTOMY. SHE ALSO UNDERWENT COOLING PROTOCOL FOR CARDIAC ARREST. CONCLUSIONS: SUCCESSFUL ANGIOPLASTY OF L CIRCUMFLEX LESION BUT COMPLICATED BY LM DISSECTION, THE LAD, AND CARDIAC ARREST. SUCCESSFUL IMPELLA IMPLANTATION. SUCCESSFUL SALVAGE ANGIOPLASTY OF THE LM, LAD, AND CX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515938 TVC INSIGHT CATHETER NIR/IVUS CORONARY IMAGING CATHETER OGZ INFRAREDX INC. NIRS-MC7-7-3.2F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R