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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC SENSATION PLUS 8 FR 50CC INTRA-AORTIC BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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MAQUET CARDIOVASCULAR LLC SENSATION PLUS 8 FR 50CC INTRA-AORTIC BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Lot Number 30000656420671
Device Problem Material Rupture (1546)
Patient Problem Failure of Implant (1924)
Event Date 03/25/2018
Event Type  malfunction  
Event Description
Iabp rupture, right femoral artery access, prompting immediate removal of the balloon.
 
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Brand NameSENSATION PLUS 8 FR 50CC INTRA-AORTIC BALLOON CATHETER
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
NJ
MDR Report Key7380839
MDR Text Key103989183
Report NumberMW5076199
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number30000656420671
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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