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

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.

• Brand Name: FIBEROPTIX IAB
• Type of Device: INTRA-AORTIC BALLOON 8FR
• Manufacturer (Section D): ARROW INTERNATIONAL; reading PA 19605
• MDR Report Key: 5603580
• MDR Text Key: 43633387
• Report Number: MW5061859
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S15D0034
• 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