BEUDAMED
    FDA Adverse Event Summary report: N

    ROTABLATOR

    MDR report key: 9778 · Received April 29, 1994

    Report

    Report Number
    9778
    Date Received
    April 29, 1994
    Report Date
    April 8, 1994
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    MKI
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING A ROTABLATOR PROCEDURE THE TIP OF THE GUIDEWIRE BROKE OFF.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR CORONARY GUIDEWIRE TYPE A MKI HEART TECHNOLOGY, INC. 22113-5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data