BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 595332 · Received April 19, 2005

    Report

    Report Number
    595332
    Event Type
    Malfunction
    Date Received
    April 19, 2005
    Date of Event
    March 28, 2005
    Report Date
    April 19, 2005
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    1. MODEL/CATALOG NO. OF THE DEVICE: 0684-00-0328 / 0684-00-0430-01 2. FINAL RESULTS OF LAB TESTING: PLEASE SEE ENCLOSED DATASCOPE PRODUCT EVAL LETTER TO THE HOSP. 3. A LAB INFLATION TEST WAS PERFORMED AND THE IAB PUMPED SATISFACTORILY AT 100 AND 140 BPM, REACHING FULL INFLATION WITHIN 5 CYCLES. NO MFG OR PRODUCT DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    A PATIENT WAS IN THE CATHERTIZATION LAB, IN CARDIOGENIC SHOCK, EF=15%, DOCTOR INSERTED INTRA-AORTIC BALLOON PUMP ,IABP, CATHETER 8FR 34CC WITH OUT DIFFICULTY. THE IABP WAS UNABLE TO PUMP AS THE CATHETER WAS NOT OPENING COMPLETELY. THE IABP WAS VIEWED UNDER FLUOROSCOPY AND THE PROXIMAL PORTION WAS INFLATING, THE DISTAL PORTION WAS INFLATING, BUT THE MEDIAL PORTION WAS NOT INFLATING. THE DOCTOR REMOVED THE CATHETER, PERFORMED AN ARTERIOGRAM TO RULE OUT AORTIC ANUERYSM. VITAL SIGNS WERE STABLE AND THERE WAS NO HARM TO THE PATIENT. NOTHING FOUND ON THE ARTERIOGRAM.THE DOCTOR THEN INSERTED A NEW 34CC CATHETER WITH OUT DIFFICULTY. THE CATHETER INFLATED PROPERLY AND THE IABP MACHINE PUMPED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INTRA-AORTIC BALLOON PUMP CATHETER DSP DATASCOPE CORP. * 0684-00-0430-01

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR