BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 7624 · Received February 3, 1994

    Report

    Report Number
    7624
    Event Type
    Injury
    Date Received
    February 3, 1994
    Date of Event
    July 9, 1993
    Report Date
    October 28, 1993
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BLOOD WAS SEEN BY THE NURSING STAFF IN THE IABP CATHETER ON 7/29/93 AT MIDNIGHT. THE CATHETER WAS REMOVED WITH GREAT DIFFICULTY FROM THE RIGHT FEMORAL ARTERY/RIGHT GROIN.THE BALLOON CATHETER FAILED AFTER ONLY 9-1/2 HOURS OF USE. DURING INSPECTION, A BULBOUS SHAPED FORMATION MEASURING APPROXIMATELY 0.5 CM IN DIAMETER FILLED WITH HARDENED BLOOD WAS FOUND AT THE TIP OF THE CATHETER.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT 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.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, VISUAL EXAMINATION. RESULTS OF EVALUATION: BALLOON. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. 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 UNKNOWN INTRA AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 9.5 FR DL PERCOR STAT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention