MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-01
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate Waveform (2536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6), a ccu rn, called into emergency support program line to request for support with an unbale to update timing alarm on a cardiosave during use, no patient harm or injury was reported.Troubleshooting revealed a damped waveform via fiber-optic catheter was present.Esp team had melissa place the console in standby and flush for 20-30 seconds using the transducer, then restart the pump.The arterial waveform quality was not improved.Melissa was unable to aspirate the inner lumen because of the facility policy but a fellow would be at the bedside shortly to do so.Continued troubleshooting included comparing the fo waveform to the transducer waveform.They were similar, 84/80 and damped.Melissa agreed to follow up with additional support needs after the fellow attempted to aspirate the inner lumen.
Additional Manufacturer Narrative
Other contact phone number: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id (b)(4).
Additional Manufacturer Narrative
Updated fields b4 g3 g6 h2 h6 type of investigation findings investigation conclusions h11.Corrected field h6 medical device problem code.Difficult or unable to monitor arterial pressure is a condition in which the intra aortic balloon pump cannot obtain a reliable arterial pressure waveform due to issues such as sensor failure fiber optic iab calibration failure or disconnection and or fiber optic break catheter lumen obstruction eg clot kink or lumen damage setup or equipment problems eg improper zeroing air bubbles damping loose connections patient related factors like low pulse pressure or arrhythmias or off label use in these situations the arterial signal becomes inaccurate or unusable for safe iabp operation since the product was not received unable to evaluate or investigate the exact root cause of difficult unable to monitor arterial pressure and based on the limited details provided by the user the exact cause of difficult unable to monitor arterial pressure was not able to be identified however causes of difficult unable to monitor arterial pressure can include one or more of the blood clot thrombus formation within the inner lumen.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected field - h6 (medical device problem code, investigation conclusions).
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES
• 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: 24321316
• Report Number: 2248146-2026-0000684
• Device Sequence Number: 15953787
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000490853(17)280715(11)250715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2026

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: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0568-01
• Device Lot Number: 3000490853
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 03/19/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/12/2026; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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.
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 93 KG