• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET INTRA AORTIC BALLOON PUMP CATHETER INTRA - AORTIC BALLOON PUMP CATHETER Back to Search Results
Catalog Number 0684-00-0480-01
Device Problem Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Date 01/05/2016
Event Type  malfunction  
Event Description
Iabp balloon rupture. Nurse called physician and advanced licensed practitioner over to assess and there was blood marching up the catheter towards the pump. Stopped the inflation and discontinued the catheter. Pt received platelets due to platelet count of 48 to help prevent bleeding with the discontinuation of the catheter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTRA AORTIC BALLOON PUMP CATHETER
Type of DeviceINTRA - AORTIC BALLOON PUMP CATHETER
Manufacturer (Section D)
MAQUET
MDR Report Key7214931
MDR Text Key98228802
Report NumberMW5074765
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 Risk Manager
Type of Report Initial
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0480-01
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 01/23/2018 Patient Sequence Number: 1
-
-