BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS RX STREAK .010 CATHETR DILATATION CATHETER

    MDR report key: 1328 · Received September 15, 1992

    Report

    Report Number
    1328
    Event Type
    Injury
    Date Received
    September 15, 1992
    Date of Event
    September 2, 1992
    Report Date
    September 2, 1992
    Manufacturer
    ACS, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING ANGIOPLASTY PROCEDURE USING AN ACS RX STREAK .010 CORONARY DILATATION CATHETER PATIENT DEVELOPED BRADYCARDIA AND TRANSIENT EPISODE OF LEFT ARM FLACCIDITY FOLLOWING 3RD INFLATION OF ACTIVITY AFTER 20 MINUTES. CATHETER EXAMINED. PERFORATION NOTED IN SHAFT OF BALLOON CATHETERDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE, UNANTICIPATED, BALLOON. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX STREAK .010 CATHETR DILATATION CATHETER BALLOON CATHETER DSP ACS, INC. 2051951

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention