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	Signal Artifact/Noise (1036); Break (1069); Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Code	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, b7, d10, g3, g6, g7, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions, component code), h11.Product was not returned so an exact cause of the issue could not be identified.However, based on our investigation, a unable to update timing issue can occur due to one or more of the following probable causes.Component failure - potential root cause breakdown: pressure signal unavailable or unreliable.Primary root cause category: timing cannot be updated because the arterial waveform required for timing reference is incorrect or absent.Fiber-optic sensor-related causes: root cause: fiber-optic arterial signal is not detected or is invalid.Contributing factors: fiber-optic calibration failure.Fiber-optic sensor disconnection.Fiber-optic cable break.Fiber-optic cable kink or excessive bending.Improper connector insertion or unsecured cable.Contamination or damage to exposed sensor tip.Use of fiber-optic iab catheter on non-maquet-compatible pumps (off-label).Inner lumen-related causes: root cause: inner lumen cannot transmit an accurate arterial pressure waveform.Contributing factors: blood clot (thrombus) formation within the inner lumen.Partial or complete inner lumen occlusion.Kinked inner lumen.Break or damage to the inner lumen wall.Resistance encountered during aspiration (indicative of occlusion).Using the inner lumen for blood sampling (degrades waveform quality).Inadequate continuous flush (not maintained at 3 cc/hr).Failure to aspirate and discard 3 cc prior to setup.Air bubbles introduced during setup or flushing.Failure to stop pumping during fast flush (embolism prevention step ignored).User error - potential root cause breakdown: pressure signal unavailable or unreliable.Primary root cause category.Timing cannot be updated because the arterial waveform required for timing reference is incorrect or absent.Operation mode/user interaction factors: root cause: timing adjustments cannot be performed correctly due to signal or workflow issues.Contributing factors.

• 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: 50346981
• Report Number: 2248146-2026-0001427
• Device Sequence Number: 17652125
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• UDI-Public: (01)10607567109633(10)3000523482(17)290112(11)260112
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/24/2026

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: 3000523482
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/01/2026; 09/22/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/21/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2026
• 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: Intra-Aortic Balloon Pump
• Patient Age: 55 YR
• Patient Sex: Male