BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS CONCORDE CORONARY DILATATION CATHETER

    MDR report key: 40542 · Received September 30, 1996

    Report

    Report Number
    2024168-1996-00012
    Event Type
    Injury
    Date Received
    September 30, 1996
    Date of Event
    August 28, 1996
    Report Date
    September 27, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    LOX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED INTO THE EMERGENCY ROOM WITH AN ACUTE MI AND SEVERE ST ELEVATIONS. DIABETIC PT WAS VERY UNSTABLE. DIAGNOSTIC CATHETERIZATION WAS PERFORMED AND INDICATED THAT THE PT'S MID RIGHT CORONARY ARTERY WAS TOTALLY OCCLUDED. A BALLOON CATHETER WAS INSERTED OVER A GUIDEWIRE TO PREDILATE THE TOTAL OCCLUSION. ONCE THE BLOCKAGE WAS OPENED, A 2.5 CATHETER AND DEVICE WAS PUT DOWN THE VESSEL USING A KISSING BALLOON TECHNIQUE TO DILATE BOTH THE PDA AND THE PDL AT THE SAME TIME. PHYSICIAN ALSO NOTED A PROXIMAL LESION LOCATED IN THE RIGHT CORONARY ARTERY. THE 4.0 CATHETER WAS PLACED WITH A GUIDEWIRE TO DILATE THE PROXIMAL RCA LESIONS. A PINHOLE RUPTURE OF THE BALLOON OCCURRED AT 10 ATMS WITH DYE EXTRAVASATION. PHYSICIAN OPTED TO NOT REPAIR DISSECTION AT THIS TIME. PT WAS GOING TO BE BROUGHT BACK TO THE CARDIAC CATH LAB FOR STENT IMPLANTATION AT A LATER DATE DUE TO THROMBUS. FURTHER REPORTED INFO INDICATED THAT DURING THE COURSE OF THE PROCEDURE, NOT RELATED TO PTCA OR THE PINHOLE RUPTURE, THE PT WAS SHOCKED AND A BALLOON PUMP WAS UTILIZED. RECENT FOLLOW-UP FROM THE ACCOUNT INDICATES THE PT HAD BEEN STENTED AND IS REPORTED AS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS CONCORDE CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ADVANCED CARDIOVASCULAR SYSTEMS, INC. NA 6030551

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R