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	Insufficient Information (4580)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an emergency support program call, a cvicu rn requested assistance on behalf of a physician regarding repositioning of a sensation plus 7.5fr.40cc intra-aortic balloon (iab) catheter.The physician reported that the chest x-ray showed the radiopaque distal marker approximately 6 cm below the carina.Further investigation determined that the patient had experienced a cardiac arrest, during which the iab catheter migrated to approximately the 6th-7th intercostal spaces, followed by a decrease in arterial pressure readings.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.This event contains both an adverse event and a product problem.Due to a temporary system limitation associated with recent fda emdr system enhancements, only the adverse event designation could be transmitted in the current submission.Product problem details are included within this report.A supplemental mdr will be submitted once the emdr utility has been updated to support transmission of both event classifications.

• 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: 50784767
• Report Number: 2248146-2026-0001536
• Device Sequence Number: 21193057
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0568-01U
• Device Catalogue Number: 0684-00-0568-01U
• Device Lot Number: 3000510286
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 204 LB