MAUDE Adverse Event Report: MAQUET MAQUET SENSATION PLUS; INTRAORTIC BALLOON PUMP CATHETER

Model Number 30000375470559

Device Problem Aspiration Issue (2883)

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

Event Date 03/11/2017

Event Type  malfunction  

Event Description

Cardiac surgeon placing the iabp catheter and could not aspirate a blood return from the aline port.Surgeon felt there may be a defect in the catheter.He had to pull this catheter and place a new one.Patient had cabg and was needing transferred to another facility who could provide lvad/transplant due to poor ef.

• Brand Name: MAQUET SENSATION PLUS
• Type of Device: INTRAORTIC BALLOON PUMP CATHETER
• Manufacturer (Section D): MAQUET
• MDR Report Key: 6416700
• MDR Text Key: 70445554
• Report Number: MW5068526
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30000375470559
• 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): Other
• Patient Age: 51 YR
• Patient Weight: 80