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 Material Rupture (1546); Defective Device (2588)

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

Event Date 12/18/2022

Event Type  malfunction  

Event Description

Getinge intra-aortic balloon pump (iabp) balloon was found to be ruptured upon placing the balloon into the sheath.It appeared to be defective prior to placement.No replacement available at this time, this was our last balloon.

• 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: 16060418
• MDR Text Key: 306256236
• Report Number: 16060418
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• UDI-Public: (01)10607567109633
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/20/2022

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: 12/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1