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
Medical Device Problem Codes	Break (1069); Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported through a direct call from the customer to the emergency support program, that during use of sensation plus 40cc balloon catheter customer requested assistance with fiber-optic sensor failure alarm.No harm to the patient was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, d2a, d2b, d3, g3, g6, h2.Corrected field - d1, d4, h6 (investigation findings).

• Brand Name: Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only
• 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: 25330170
• Report Number: 2248146-2026-0001084
• Device Sequence Number: 18612230
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2026

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: 0684-00-0568-01U
• Device Catalogue Number: 0684-00-0568-01U
• Device Lot Number: 3000485984
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 07/17/2026; 08/31/2026; 09/15/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/20/2026; 09/10/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 200 LB