BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTCA CATHETER

    MDR report key: 1203369 · Received October 15, 2008

    Report

    Report Number
    2134265-2008-03037
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Report Date
    November 29, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE HAS BEEN DISPOSED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINANT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PERCUTANEOUS INTERVENTIONAL PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION LOCATION IS UNKNOWN. THE TORTUOSITY OF THE VESSEL IS UNKNOWN. THE DEGREE OF STENOSIS AND LEVEL OF CALCIFICATION ARE UNKNOWN. THE NC MONORAIL 15X4.0MM BALLOON BURST. THE INFLATION TIME AND ATMS ARE UNKNOWN. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC NCM 15/4.0

    Patients

    Seq Age Sex Outcome Treatment
    1