MAUDE Adverse Event Report: ARROW INTRAAORTIC BALLOON

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.

• Brand Name: INTRAAORTIC BALLOON
• Type of Device: INTRAAORTIC BALLOON
• Manufacturer (Section D): ARROW
• MDR Report Key: 7013687
• MDR Text Key: 91879149
• Report Number: MW5073214
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR