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
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6 (medical device ¿ problem code, type of investigation, investigation findings, investigation conclusions), h11.\ \ the reported problem was most likely caused by a membrane leak that allowed blood to enter the balloon.Microscopic examination of the leak site revealed a whitish patch surrounding the defect.This appearance is characteristic of an abrasion mark and is consistent with damage caused by contact with calcified plaque within the aorta.The observed kink in the catheter tubing was also noted during evaluation.\ \ this issue continues to be monitored within the manufacturer¿s quality system.
Event or Problem Description
N/a.
Event or Problem Description
During an emergency support program call, a cvicu fellow reported a catheter restriction alarm during support with a sensation plus 8fr.50cc intra-aortic balloon (iab).The customer had turned the pump off, and therapy had been discontinued for approximately 30 minutes at the time of the call.Due to the duration of the pump being off and the associated risk of thrombus formation, the customer was advised to remove the iab catheter.The nature of the catheter restriction alarm was reviewed, and the customer confirmed that the plan was to remove the iab catheter.No patient harm or injury was reported.
Additional Manufacturer Narrative
Event site name: (b)(6).\ upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: Sensation Plus 8Fr. 50cc 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: 50911911
• Report Number: 2248146-2026-0001573
• Device Sequence Number: 5776378
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Device Lot Number: 3000535319
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown