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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET MAQUET INTRA-AORTIC BALLOON CATHETER

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MAQUET MAQUET INTRA-AORTIC BALLOON CATHETER Back to Search Results
Lot Number 3000021033
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Date 02/29/2016
Event Type  Injury  
Event Description
Patient status post nstemi underwent cardiac cath on (b)(6) 2016, when the iabp was placed. On (b)(6), the balloon pump was alarming "catheter restriction. " condensation, as well as specks of blood were noted in the helium line. Call placed to manufacturer recommended removal. Inspection of catheter noted a rupture of the balloon.
 
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Brand NameMAQUET
Type of DeviceINTRA-AORTIC BALLOON CATHETER
Manufacturer (Section D)
MAQUET
MDR Report Key5503801
MDR Text Key40555969
Report NumberMW5060910
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/04/2018
Device Lot Number3000021033
Was Device Available for Evaluation? Yes
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: 03/14/2016 Patient Sequence Number: 1
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