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 Codes	Difficult to Flush (1251); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an emergency support program call, the customer reported loss of the arterial pressure waveform after the patient had been ambulating and returned from the bathroom.Multiple attempts to flush the sensation plus 7.5fr.40cc intra-aortic balloon (iab) inner lumen were unsuccessful, and the inner lumen was considered clotted; guidance was provided to cap and label the inner lumen and discontinue use.The fiber-optic source was reportedly not being used due to a previously reported issue, although it had functioned as expected during a prior call on 17 august.The customer declined further fiber-optic troubleshooting and planned to obtain an alternate arterial pressure source via radial arterial line.The iab was axillary placed, and the appropriate axillary placement considerations were reviewed.
Additional Manufacturer Narrative
An investigation was conducted regarding failure of the xxxx in the intra-aortic balloon (iab).Clotted inner lumen is a blockage of the catheter¿s inner channel, and it is typically caused by blood clot (thrombus) formation within that lumen.When the inner lumen becomes occluded by a blood clot, it can no longer transmit accurate arterial pressure.The clotted inner lumen can occur due to one or more of the following factors: inadequate flushing of the inner lumen.Kink in the inner lumen.Iab remaining inactive/standby for more than 30 minutes.These conditions may promote a slow blood flow within the inner lumen, leading to thrombus formation and occlusion.Once clotted, the inner lumen can no longer transmit accurate arterial pressure waveforms.Per ifu guidelines, failure to aspirate and flush the lumen immediately after catheter placement or when waveform damping is observed increases the risk of clot formation.In cases where resistance is met during aspiration or flushing is unsuccessful, the lumen should be considered occluded and discontinued from use.This issue continues to be monitored within the manufacturer¿s quality system.

• 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: 50750560
• Report Number: 2248146-2026-0001522
• Device Sequence Number: 8495174
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/14/2026

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: 0684-00-0568-01U
• Device Catalogue Number: 0684-00-0568-01U
• Device Lot Number: 3000478158
• 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: 08/22/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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: CARDIOSAVE Intra-Aortic Balloon Pump (IABP).
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 182 LB