MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0271

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 08/15/2015

Event Type  Death  

Manufacturer Narrative

Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.(b)(6).

Event Description

Sensation plus 50cc balloon inserted in female patient in cath lab during stemi- patient very unstable, coded several times- cpr and defibrillation done upon insertion of the fiber optic balloon the pump alarmed iab optical sensor failure.Nurse stated that they also switched out the pump just to be sure it was a catheter issue and the iab optical sensor failure occurred again.They did remove the sensor and re insert- recalibration attempted with same alarm.They switched to central aortic fluid column for bp readings and received an arterial pressure waveform on the screen with readings.Pump supported the patient with ecg trigger the entire time.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 5080942
• MDR Text Key: 25988683
• Report Number: 2248146-2015-01016
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 58 YR