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 Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by direct call from the customer to the emergency support program, that during use of sensation plus 40cc balloon catheter the inner lumen of the iab catheter was clotted; customer was advised to remove the fluid-filled pressurized bag from the inner lumen and label it "do not use" due to the risk of thrombus.The fiber-optic (fo) cable was being used as the arterial pressure source.The customer reported a lead fault on a cardiosave iabp in auto mode, intermittently switching to pressure trigger.The customer was advised to replace the ecg electrodes, apply doppler gel, and reposition the electrodes closer to the heart to improve conduction.At the time of the call, the ecg waveform was clean, and the customer agreed to follow the recommendations if needed.No harm to the patient reported.
Additional Manufacturer Narrative
An investigation was conducted regarding clotted inner lumen in the sensation plus 7.5fr.Balloon 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: 50814049
• Report Number: 2248146-2026-0001547
• Device Sequence Number: 10152482
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• UDI-Public: (01)10607567109565(10)3000526761(17)290205(11)260205
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/18/2026

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: 3000526761
• 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: 08/29/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• 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: CARDIOSAVE I (IABP) OT1601709.
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 195 LB