BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS TOURGUIDE CORONARY GUIDING CATHETER/GUIDING CATHETER

    MDR report key: 37338 · Received September 6, 1996

    Report

    Report Number
    2024168-1996-00003
    Event Type
    Injury
    Date Received
    September 6, 1996
    Date of Event
    August 6, 1996
    Report Date
    September 5, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PATIENT STATUS FROM A HOSPITAL OR FIELD CONTACT. EVALUATION SUMMARY: THE RESULTS OF THE INVESTIGATIVE ANALYSIS REVEALED A KINK CLOSE TO THE HUB OF THE DEVICE. THE TIP SHAPE WAS RELAXED, AS TO BE EXPECTED AFTER USE, BUT NO ANOMALIES IN THE TIP WERE NOTED. ENGINEERING CONCLUDED THAT THE PROBABLE CAUSE OF THE CATHETER BECOMING KINKED WAS A RESULT OF ONE OR A COMBINATION OF THE FOLLOWING: OVERTORQUING, TORTUOUS PATIENT ANATOMY, STRAIGHTENING OF THE DISTAL TIP DURING INSERTION INTO THE SHEATH, AND OR ENGAGEMENT INTO THE CORONARY ARTERY OSTIUM WITHOUT PROPER SUPPORT. A REVIEW OF THE MFG DATA FOR THS DEVICE FOUND NO ABERRANCIES. ENGINEERING HAS CONCLUDED THAT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. QUALITY ASSURANCE WILL MONITOR THE DEVICE FOR THE TYPE OF COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPARTMENT.

    Description of Event or Problem · 1

    A DISSECTION WAS NOTED DURING ATTEMPTS TO POSITION THE GUIDING CATHETER IN THE PT. THE PT WAS SENT TO SURGERY AND IS REPORTED AS DOING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS TOURGUIDE CORONARY GUIDING CATHETER/GUIDING CATHETER GUIDING CATHETER DYB ADVANCED CARDIOVASCULAR SYSTEMS, INC. NA 6050251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R