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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP SENSATION PLUS; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP SENSATION PLUS; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0568-01U
Device Problem Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Date 05/21/2018
Event Type  malfunction  
Event Description
Balloon rupture which resulted in removing existing balloon pump and entire new system inserted.Doctor called in, cath lab personnel called in and numerous x-rays needed for placement.Patient was previously extremely dependent on iabp, vasoactive gtts needed to be increased during time iabp was not functioning.The balloon was thrown away but the cath lab staff kept all of the information about it.The patient is sick but not because of this situation.He did require some increased vasoactive drugs when this occurred and some extra x-rays.
 
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Brand Name
SENSATION PLUS
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP
15 law drive
fairfield NJ 07004
MDR Report Key7595751
MDR Text Key110874681
Report Number7595751
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 Other
Type of Report Initial
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number0684-00-0568-01U
Device Catalogue Number0684-00-0568-01U
Device Lot Number3000067529
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/25/2018
Event Location Hospital
Date Report to Manufacturer05/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Age65 YR
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