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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL FIBEROPTIX IAB INTRA-AORTIC BALLOON 8FR

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ARROW INTERNATIONAL FIBEROPTIX IAB INTRA-AORTIC BALLOON 8FR Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem No Code Available (3191)
Event Date 04/14/2016
Event Type  Injury  
Event Description
Pt was a non-stemi from ed taken to cardiac cath lab for assessment and intervention. After cardiac catheterization, an intra-aortic balloon was inserted on (b)(6) 2016. On (b)(6) 2016 at 0500, blood was noted in the balloon catheter. Attempts to remove intra-aortic balloon was unsuccessful and required surgical intervention. Pt is still hospitalized, but doing well.
 
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Brand NameFIBEROPTIX IAB
Type of DeviceINTRA-AORTIC BALLOON 8FR
Manufacturer (Section D)
ARROW INTERNATIONAL
reading PA 19605
MDR Report Key5603580
MDR Text Key43633387
Report NumberMW5061859
Device Sequence Number1
Product Code DSP
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 04/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2017
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18S15D0034
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? 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: 04/20/2016 Patient Sequence Number: 1
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