BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS TX 2000 CORONARY DILATATION CATHETER

    MDR report key: 40537 · Received September 30, 1996

    Report

    Report Number
    2024168-1996-00011
    Event Type
    Injury
    Date Received
    September 30, 1996
    Report Date
    September 27, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS INC
    Product Code
    LOX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTIAN COMPLETE INFO OF THE EVENT AND PT STATUS FROM THE HOSPITAL, DISTRIBUTOR, OR FIELD REPRESENTATIVE.

    Description of Event or Problem · 1

    DURING PTCA OF A TORTUOUS LESION LOCATED IN THE PT'S LEFT CIRCUMFLEX, THE BALLOON REMAINED INFLATED FOR 90 SECONDS (REF. MFR RPT. #2024168-1996-00010). THE PT DID NOT EXPERIENCE ANY ST CHANGES DURING THIS TIME. THE BALLOON WAS SUCCESSFULLY DEFLATED AND WAS REMOVED FROM THE PT. THE PHYSICIAN OPTED FOR PLACING ANOTHER DILATATION CATHETER INSIDE THE PT FOR FURTHER INFLATION TO OPTIMIZE THE RESULT OF THE PTCA. AFTER FURTHER INFLATION WITH THE SECOND BALLOON CATHETER, A DISSECTION WAS NOTED. THE BALLOON DEFLATION TIME ON THE SECOND CATHETER WAS REPORTED TO BE 58 SECONDS. THE DEVICE WAS REMOVED FROM THE PT AND THE DISSECTION WAS SUCCESSFULLY TACKED WITH ANOTHER BALLOON CATHETER. THE PT IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS TX 2000 CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ADVANCED CARDIOVASCULAR SYSTEMS INC NA 6061851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention