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

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

  • 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 IABP BALLOON INTRA - AORTIC BALLOON Back to Search Results
Model Number 0684-00-0294-01U
Device Problems Break (1069); Entrapment of Device (1212); Material Rupture (1546)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/02/2017
Event Type  Injury  
Event Description
This is a (b)(6) y/o lady who was admitted on (b)(6), 2017 with complaints of chest tightness. She was diagnosed with a nstemi. She underwent a cardiac catheterization and an iabp was placed. On (b)(6), she went back to the cath lab to have a pci of the lad (95% occlusion) and left main (80% occlusion). On (b)(6) the iabp ruptured possibly due to the calcification in her aorta. When removing the balloon, a piece of the tip broke off and was retained. She was taken to the cath lab to attempt to remove the sheath and tip under fluoroscopy. Ultimately she had to be taken emergently to the operating room for removal by vascular surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIABP BALLOON
Type of DeviceINTRA - AORTIC BALLOON
Manufacturer (Section D)
MAQUET
MDR Report Key6386877
MDR Text Key69510181
Report NumberMW5068328
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0684-00-0294-01U
Device Lot Number3000015058
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

Patient Treatment Data
Date Received: 03/06/2017 Patient Sequence Number: 1
-
-