MAUDE Adverse Event Report: MAQUET GETINGE GROUP SENSATION PLUS 8 FR IAB CATHETER

Model Number 0684-00-0576-01U

Device Problems Break (1069); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 07/24/2016

Event Type  Injury  

Event Description

On (b)(6) 2016 patient had a 50cc sensation plus iab catheter placed in the cath lab. On (b)(6) 2016 at approx. 0553 the balloon pump began to alarm "gas loss in circuit," at this time the respiratory therapist checked all the connections. No blood was found at this time. The balloon was auto filled, restarted and quickly alarmed again. Upon inspection the catheter and helium line were found to have blood in them. The pump was stopped and the catheter was clamped off to stop the backwards flow of blood. The cardiologist came in to replace the damaged balloon. When the second replacement balloon was inserted it was found to be damaged (torn). The third balloon was placed and therapy restarted. The patient was transferred back to cicu. On (b)(6) 2016 at about 1235 the pump once again began to alarm "gas loss in circuit. " it was quickly discovered that once again there was blood in the catheter and helium line. The therapist clamped the catheter and helium line. This catheter was removed by the physician. It was decided that it would not be replaced, as the plan was to remove it that day anyway. About an hour later, the patient coded and expired.

• Brand Name: SENSATION PLUS 8 FR IAB CATHETER
• Type of Device: SENSATION PLUS 8 FR IAB CATHETER
• Manufacturer (Section D): MAQUET GETINGE GROUP
• MDR Report Key: 5846122
• MDR Text Key: 51241678
• Report Number: MW5063832
• 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

• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/14/2019
• Device Model Number: 0684-00-0576-01U
• Device Lot Number: 3000032904
• Was Device Available for Evaluation?: Yes
• 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?: Yes

Type of Device Usage

Patient Treatment Data

Date Received: 08/01/2016 Patient Sequence Number: 1