BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 10.5 FR. 50CC. IAB

    MDR report key: 167069 · Received May 8, 1998

    Report

    Report Number
    2248146-1998-00495
    Event Type
    Malfunction
    Date Received
    May 8, 1998
    Date of Event
    April 29, 1998
    Report Date
    April 29, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS WAS DISCUSSED WITH CARDIAC ASSIST FILES INITIAL MEDWATCH REPORTS BASED ON THE INFO PROVIDED BY THE COMPLAINANT AT THE TIME THE INFO IS REC'D. INITIAL REPORTS MAY INDICATE A CONCLUSION CODE WHICH IS "NO CONCLUSION CAN BE DRAWN." THIS IS THE MOST ACCURATE RESPONSE AT THAT TIME SINCE PRODUCT HAS NOT YET BEEN RETURNED FOR EVALUATION. SHOULD THE PRODUCT BE RETURNED AT A LATER DATE, AN EVALUATION IS PERFORMED AND A F/U MEDWATCH IS FILED WITH A DIFFERENT CONCLUSION CODE THAT REPRESENTS THE OUTCOME. CARDIAC ASSIST REVISITED THE MEDWATCH REPORTS THAT ARE REFERENCED ABOVE TO FIND OUT WHERE REMEDIAL ACTION WAS IMPLIED. HER CONCLUSION WAS THAT THESE REPORTS DID NOT INDICATE, NOR IMPLY, REMEDIAL ACTION AND SHE ADVISED THAT THIS QUESTION SHOULD BE IGNORED. CO REQUEST THAT CO'S COMPLAINANTS RETURN PRODUCT FOR IN-HOUSE EVALUATIONS. COMPLAINTS THAT ALLEGE THESE POSSIBLE FAILURE MODES; CLOTS, FRACTURES, KINKS, ELONGATION ARE NO EXCEPTION. AS A RESULT OF CO'S EVALUATIONS, CO'S RATE OF CONFIRMED CENTRAL LUMEN BREAKS HAS AVERAGED .018% IN THE LAST THREE FISCAL YEARS. AS EXPLAINED TO THE CARDIAC ASSIST, IT'S BEEN CO'S EXPERIENCE THAT THESE FAILURE MODES ARE MOSTLY LIKELY ATTRIBUTED TO USER HANDLING, BALLOON PLACEMENT, PT ANATOMY, REMOVAL FROM THE PACKAGING TRAY AND NOT A DEFECT OF THE CATHETER'S INNER/CENTRAL LUMEN.

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT VIA A SURGICAL CUTDOWN. THE IAB LEAKED BACK INTO THE SYS 97 PUMP. WHEN THE IAB WAS REMOVED SURGICALLY, IT WAS NOTED TO BE DAMAGED. NO SECOND IAB WAS INSERTED INTO THE PT. ON 6/10/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLOOD WAS NOTED IN THE CATHETER AND THE GAS SHUTTLE LINE. THE CATHETER WAS REMOVED AND WAS RINSED OUT. IT WAS DISCOVERED THAT THE CENTRAL LUMEN WAS BROKEN. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 4/29/98. THE PT WAS STABLE AFTER THE EVENT. [EVENT COMPLICATIONS]: UNK-REPORTED 4/29/98; NONE-RPT'D 6/10/99. [PT'S CURRENT STATUS]: STABLE-RPT'D 6/10/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 10.5 FR. 50CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0194 5/10/98

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR