BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THROMCAT THROMECTOMY CATHETER

    MDR report key: 1917408 · Received December 2, 2010

    Report

    Report Number
    1721279-2010-00077
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 17, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MCW
    PMA / PMN Number
    K060016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVICES RETURNED FOR ENGINEERING ANALYSIS. THE RESULTS OF AN INTERNAL DEVICE LOT HISTORY REVIEW FOUND NO ISSUES OR NON-CONFORMANCES. (B)(4).

    Description of Event or Problem · 1

    THE REASON FOR THIS MDR IS TO REPORT AN ADVERSE EVENT THAT OCCURRED IN (B)(6). A THROMCAT WAS USED TO TREAT A SUB-ACUTE OCCLUSION OF THE RCA. DURING THE SECOND PASS, A PERFORATION OF THE RIVP (RIGHT INTERVENTRICULAR POSTERIOR BRANCH OR PDA) OCCURRED, AS WELL AS A PERICARDIAL EFFUSION AND AV FISTULA. THE INJURY WAS REPAIRED AND THE PATIENT RECOVERED FROM THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT THROMECTOMY CATHETER THROMCAT MCW SPECTRANETICS CORP. 63000-02 82260

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention