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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0568-01U
Device Problems Backflow (1064); Fracture (1260); Material Rupture (1546); Noise, Audible (3273)
Patient Problems Low Blood Pressure/ Hypotension (1914); Foreign Body In Patient (2687)
Event Date 12/04/2018
Event Type  Injury  
Event Description
Patient had an iabp placed prior to a cabg surgery. Following, the iabp became loud and blood was baking up into the tubing. The balloon had ruptured inside of patient. Surgeon removed catheter and placed a new one. The next day, iabp began alarming to "check catheter" when in 1:1. It ran without issue on 1:2. Iabp helium tubing was noted to have blood flecks in it. The balloon had ruptured again inside of patient. The provider attempted to remove the iabp through the sheath and the catheter fractured. Sheath and remaining portion of catheter were then removed. Pts. Blood pressure decreased during manual compression requiring albumin, levophed and dobutamine. Hemoglobin dropped from 9. 4 to 7. 1 by the following morning. Pt. Required 1 unit of prbcs.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key8168740
MDR Text Key130469895
Report Number8168740
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0568-01U
Device Catalogue Number0684-00-0568-01U
Device Lot Number30000550380302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2018
Event Location Hospital
Date Report to Manufacturer12/17/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
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