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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SENSATION BALLOON CATHETER

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MAQUET SENSATION BALLOON CATHETER Back to Search Results
Catalog Number 0684-00-0469-01U
Device Problem Leak/Splash (1354)
Patient Problems Death (1802); No Code Available (3191)
Event Date 05/28/2016
Event Type  Injury  
Event Description
Intraaortic balloon pump catheter noted to have balloon malfunction (leak) while in use on patient with post stemi acute hemodynamic collapse. Balloon changed out and second balloon functioned as designed. Patient subsequently expired on (b)(6) 2016 after post stemi development of ventricular septal defect and akinetic right ventricle.
 
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Brand NameSENSATION BALLOON CATHETER
Type of DeviceSENSATION BALLOON CATHETER
Manufacturer (Section D)
MAQUET
fairfield NJ 07004
MDR Report Key5697762
MDR Text Key46568962
Report NumberMW5062614
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/13/2018
Device Catalogue Number0684-00-0469-01U
Device Lot Number3000016155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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: 05/31/2016 Patient Sequence Number: 1
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