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 Problem Defective Device (2588)

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

Event Date 12/27/2022

Event Type  malfunction  

Event Description

When the drapes were pulled off, perfusionist noticed there was blood in the balloon pump's helium line and they needed to remove the balloon pump.The balloon pump was placed prior to entering the or in the cath lab.Perfusionist advised doctor that the pump needed to be removed in this condition.Doctor advised physician's assistant remove the balloon pump.After it was removed, perfusionist inspected the balloon for holes and did not see any leaks evident.

• 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; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 16768441
• MDR Text Key: 313593334
• Report Number: 16768441
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Male
• Patient Weight: 107 KG