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 Codes	Deflation Problem (1149); Difficult to Insert (1316); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, b6, b7, d10, d9, g3, g6, g7, h2, h3, h4, h6 (medical device problem code, component codes, type of investigation, investigation findings and investigation conclusions), h11.Corrected fields: d4 serial (revert this field to blank, as it was inadvertently submitted initially) and d8 (revert this field to blank, as it was inadvertently submitted initially).The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter.The one-way valve was also returned.The sheath was not returned for evaluation.The one way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.Difficult or unable to draw vacuum on iab was unable to be confirmed.Additionally we are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.Per ifu the one way valve must be aspirated to 30cc while leaving the one way valve in place attached to the extracorporeal tubing leur to ensure vacuum is maintained throughout insertion.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.The investigation does not indicate that the device was inadvertently released as non conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend.Based on the rational provided above, no escalation to the capa process is required.

• 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: 50079529
• Report Number: 2248146-2026-0001344
• Device Sequence Number: 13316735
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• UDI-Public: (01)10607567109633(10)3000511517(17)281105(11)251105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 3000511517
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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: Unknown
• Patient Age: 74 YR
• Patient Sex: Male