MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0568-01U

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/03/2022

Event Type  malfunction  

Event Description

Balloon pump was placed on a patient when sensor failure alarm sounded.Rep was contacted via the number provided on the balloon pump machine.Rep stated that this was a failure within the catheter and not an issue with the machine itself.Rep requested further information regarding the event which was sent via email.Physician op note: an intraoperative balloon pump was then placed up the left femoral access site and positioned in the upper portion of the descending thoracic aorta.However, upon balloon pump initiation, there appeared to be a communication issue with the balloon pump console, and we could never record pressures off the balloon pump console.We were able to observe pressures however off the arterial access alone.The balloon pump was placed on standby and the patient's blood pressure appeared to be stable.The guiding catheter was then removed.The balloon pump wire was placed back through the balloon pump.The balloon pump was then pulled back and the perclosure sutures were secured down with good hemostasis in the left femoral access site.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 15163188
• MDR Text Key: 297225884
• Report Number: 15163188
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0568-01U
• Device Catalogue Number: 0684-00-0568-01U
• Device Lot Number: 3000169723
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Weight: 54 KG
• Patient Race: Black Or African American