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	Fluid/Blood Leak (1250); Difficult to Remove (1528)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Vascular Problem (4441); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11.Corrected field: d4 (udi).The customer noted that patient-related factors such as age and vascular condition may have contributed to the event.Additional follow up indicated that the service representative was not requested to inspect or service the pump, and no blood back condition within the pump was reported.The device was retained by the customer for potential evaluation.A medical assessment was preformed and it concluded that the event is consistent with an iab membrane perforation, with therapy continuing despite indications of catheter perforation as outlined in the ifu.The resulting difficult catheter removal and vascular injury led to a hematoma and vessel repair; however, excessive force during removal cannot be confirmed as the cause.The reported complications are known risks already documented in the product risk file, and no new hazards were identified; therefore, no further escalation is required.The reported blood and clotting within the balloon and helium lumen are consistent with a potential balloon membrane breach, rupture, or fracture that may have allowed blood ingress into the catheter system.Difficulty during catheter removal and the subsequent hematoma could have been influenced by patient-specific factors, including vascular anatomy, vessel condition, procedural complexity, or tissue trauma associated with catheter placement and removal.Additionally, prolonged dwell time, vascular calcification, resistance encountered during removal, or mechanical stress on the balloon catheter may have contributed to the observed condition.Based on the available information, the exact cause cannot be conclusively determined without device evaluation.No decon or visual inspection performed since product was not returned and could not be evaluated.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to 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 (increase in number of complaints over past three (3) months).The risk review was performed and no new risks, failure modes, causes or harms were identified.The trend review did not identify any adverse trends.No escalations are required at this time.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: 50194648
• Report Number: 2248146-2026-0001386
• Device Sequence Number: 6111078
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Device Lot Number: 3000525520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: 08/10/2026; 08/21/2026; 09/15/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 08/11/2026; 09/08/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 217 LB