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 Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
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
During an emergency support program call, assistance was requested with a supraoptimal augmentation on a cardiosave intra-aortic balloon pump (iabp) using a sensation plus 7.5fr.40cc intra-aortic balloon (iab) during support.The iab tip was reported to be positioned between the 4th and 5th intercostal spaces.The recommendation for positioning between the 2nd and 3rd intercostal spaces was discussed; however, it was reported that the physician considered the placement appropriate based on the patient¿s anatomy.No harm was reported.

• 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: 50472304
• Report Number: 2248146-2026-0001459
• Device Sequence Number: 13255036
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• UDI-Public: (01)10607567109565(10)3000365109(17)270209(11)240209
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 3000365109
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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: CARDIOSAVE IABP, (b)(6).
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 125 LB