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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
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 will not be returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. 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 second iab used in this event. A separate report will be submitted for the first 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
dorota wolpiuk
15 law drive
fairfield, NJ 
MDR Report Key12013141
MDR Text Key256636947
Report Number2248146-2021-00387
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/31/2021
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? No
Device Operator
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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