MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC SENSATION PLUS 8FF 50 CC FIBER-OPTIC BALLOON CAHTETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2018

Event Type  Injury  

Event Description

Sensation plus 8ff 50cc fiber-optic balloon catheter was inserted and connected to the iabp console.When the console was started, the error message auto-fill failure would not allow the catheter to function.A second attempt was made with the same results and an inability to provide the therapy to the pt.The field rep stated that this has been a known issue and that he had not called or notified us of the issues experienced at high elevations.

• Brand Name: SENSATION PLUS 8FF 50 CC FIBER-OPTIC BALLOON CAHTETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC
• MDR Report Key: 7717904
• MDR Text Key: 115093419
• Report Number: MW5078582
• 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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): Hospitalization
• Patient Age: 58 YR