MAUDE Adverse Event Report: GETINGE / DATASCOPE CORP. SENSATION PLUS 7. 5FR 40CC INTRA AORTIC BALLOON CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number MAGUET SENSATION PL

Device Problem Pressure Problem (3012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)

Event Date 03/02/2021

Event Type  Injury  

Event Description

The patient was about to have emergent coronary angiography, became hypotensive, developed vf and received multiple rounds of defibrillation, cpr and inotropes.The team then placed an iabp.The patient arrested again and received at 6 minutes f cpr with aggressive resuscitation efforts.A 40cm iabp was placed in excellent position and set at 1:1.There was initially excellent augmentation however over several minutes time the map persistently dropped requiring confirmation of central pressures with the use of an omniflush catheter placed in the proximal aorta.Again the patient became hypotensive to the 40s systolic despite aggressive inotropes.The balloon pump waveform had an odd appearance that suggested the patient had no underlying native pressure.This was confirmed by putting the balloon pump on hold which demonstrated no native pressure.Aggressive cpr and resuscitative efforts were reinstituted for an additional 5 minutes which did not result in restoration of a perfusing pressure or rhythm.Therefore all further efforts at resuscitation.

• Brand Name: SENSATION PLUS 7. 5FR 40CC INTRA AORTIC BALLOON CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): GETINGE / DATASCOPE CORP.
• MDR Report Key: 11633723
• MDR Text Key: 244681993
• Report Number: MW5100639
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: MAGUET SENSATION PL
• Device Lot Number: 3000120750
• 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: 61 YR
• Patient Weight: 82