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

MAUDE Adverse Event Report: ARROW INTRAAORTIC 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
 

ARROW INTRAAORTIC BALLOON Back to Search Results
Device Problem Material Rupture (1546)
Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816)
Event Date 10/10/2017
Event Type  Injury  
Event Description
Patient with increased sob and critical aortic stenosis had cath and iabp insertion on (b)(6). At approximately 0430 patient restless and noted to have blood in helium tubing due to iabp rupture. Balloon was turned off and patient sent to cath lab for replacement of iabp in left femoral.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTRAAORTIC BALLOON
Type of DeviceINTRAAORTIC BALLOON
Manufacturer (Section D)
ARROW
MDR Report Key7013687
MDR Text Key91879149
Report NumberMW5073214
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 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
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: 11/09/2017 Patient Sequence Number: 1
-
-