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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01
Device Problems Filling Problem (1233); Calibration Problem (2890)
Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012); Cardiac Tamponade (2226); Low Cardiac Output (2501); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Event Date 05/25/2021
Event Type  Death  
Manufacturer Narrative
The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed. Complaint record id # (b)(4).
 
Event Description
It was reported that once the patient had returned from a coronary artery bypass graft (cabg) x8, he had significant bleeding shown on his computerized tomography (ct) scans. Approximately four hours later, the patient was administered calcium chloride. Intravenous pyelogram (ivp) showed low heartrate (hr), low sustained virologic response (svr), low cardiac output (co), and low blood pressure (bp). An echocardiogram was done at bedside and revealed the patient had cardiac tamponade. The final report showed left ventricular ejection fraction (lvef) was 30% with anterior and apical akinesis of the left ventricle as well as mild mitral regurgitation (mr) and tricuspid regurgitation (tr). There was also a trivial pericardial effusion and some element of a pleural effusion. Another chest x-ray was done showing a tiny right apical pneumothorax and a pneumopericardium. As the patient's status continued to decline, the physician emergently inserted the intra-aortic balloon (iab). After insertion of the iab, the console indicated that there was an auto-fill failure, unable to calibrate optic sensor, and to check the iab. After about two minutes, the decision was made to remove the iab and insert a new one. The second iab was connected and began to work successfully. After approximately one hour, the patient coded and pulseless electrical activity (pea) cardiopulmonary resuscitation (cpr) was started. The patient expired about one hour later due to sudden cessation of cardiac activity with no return of cardiac activity even after iab placed, placing pacer on pressors, administering fluids, and blood. This report is for the first iab used in this event. A separate report will be submitted for the second iab.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key12012985
MDR Text Key256637464
Report Number2248146-2021-00386
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/05/2022
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000089609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2019
Is the Device Single Use? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 06/16/2021 Patient Sequence Number: 1
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