MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-01
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint was received through a direct call from the customer to the emergency support program.Troubleshooting was performed with the nurse and determined that the catheter was working as intended.No patient harm or injury was noted.Troubleshooting identified the nature of the alleged issue and reviewed that the catheter was functioning appropriately given the patient¿s clinical picture and position of the balloon.The alleged issue was not related to a device malfunction, rather user error.An rn in the cvicu, called with low blood pressure and higher augmentation.She stated the patient had just arrived from the cath lab a short time ago.Shreya explained the patient¿s blood pressure seemed lower than she would expect despite the mean being ok.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected field: h3.
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 24853852
• Report Number: 2248146-2026-0000880
• Device Sequence Number: 10475794
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000495817(17)280826(11)250826
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3000495817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/28/2026; 05/10/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/05/2026; 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IABP.
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 55 KG