MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01U

Device Problems Unable to Obtain Readings (1516); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2021

Event Type  malfunction  

Event Description

During surgical procedure for coronary bypass, device was placed into patient's aorta via femoral artery.The fiber optic cable at end of device should read patient's blood pressure.The device did not start and sync.Error message from machine "iab optical sensor failure.Rep was called to trouble shoot.Device stayed in for the majority of the surgical procedure.Patient's arterial pressure and ekg were used for the trigger and reading.Device was exchanged with a new balloon after cross clamp removed but not off bypass.The patient's status did not change from original device and exchanged with new device.The device was sequestered and returned to vendor.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 12473764
• MDR Text Key: 271507103
• Report Number: 12473764
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Device Lot Number: 3000148556-01U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Date Report to Manufacturer: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18980 DA