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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01U
Device Problems Partial Blockage (1065); Entrapment of Device (1212); Device Displays Incorrect Message (2591)
Patient Problems Failure of Implant (1924); Thrombus (2101)
Event Date 01/05/2018
Event Type  malfunction  
Event Description
Intra-aortic balloon pump (iabp) was put in prior to coronary artery bypass graft (cabg) surgery. During surgery, the balloon pump console gave alarm and a small amount of blood was noticed in the helium line. The line was replaced and the alarms were cleared and the iabp began to function as normal. During patient's recovery (after cabg, in cardiac care unit [ccu]), the balloon pump console again gave an alarm. The doctor was called and he decided to remove balloon. Upon removal of the balloon, the surgeon was unable to get the balloon through the sheath. The patient had to be taken to the operating room for open surgical removal. An arterial cutdown was performed to remove the balloon, and "rock hard" clotted blood was found inside the balloon that was keeping it from deflating. The balloon was sent to pathology for evaluation. Manufacturer response for sensation 40cc 7fr fiber optic balloon cath, (per site reporter) : they will want to examine the balloon and initiate a quality control investigation.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key7198931
MDR Text Key97542947
Report Number7198931
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0470-01U
Device Catalogue Number0684-00-0470-01U
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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