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	Inability to Auto-Fill (1044); Restricted Flow rate (1248); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an emergency support program call, an autofill failure alarm was reported on a cardiosave intra-aortic balloon pump (iabp) during patient support with a sensation plus 7.5fr.40cc intra-aortic balloon (iab) catheter.Prior to the call, the original pump had displayed gas loss, gas gain, and autofill failure alarms.In an attempt to resolve the issue, the clinical team exchanged the pump; however, the replacement pump also displayed an autofill failure alarm.Multiple attempts to resume therapy using the iab fill and start keys on both pumps were unsuccessful, with the alarm recurring each time.The customer reported the iab catheter had been inserted via the axillary approach, had been in place for five days, and the patient had been sitting upright.No blood or discoloration was observed in the helium tubing, all tubing connections were secure, and no external kinks were identified.A chest x-ray was pending at the time of troubleshooting.Multiple interventions to relieve a suspected catheter kink were unsuccessful.A cardiac physician assistant attempted to remove sutures and relieve a suspected external kink without success.After the iab had remained in standby for approximately 24 minutes with an inability to resume therapy, the cardiac surgeon determined that the suspected catheter kink could not be relieved and elected to remove the iab catheter.A biohazard kit was requested for return of the iab catheter for analysis.During follow-up, the customer confirmed the iab catheter had been successfully removed, the patient was doing well, and the clinical team planned to insert a replacement iab catheter later that day.No patient harm or injury was reported.
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Upon completion of the investigation into this event a follow up report will be submitted.

• 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: 50449721
• Report Number: 2248146-2026-0001453
• Device Sequence Number: 18712490
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• UDI-Public: (01)10607567109565(10)3000522295(17)290106(11)250106
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/26/2026

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: 3000522295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2026
• 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 IAB 1585712 and 1585709
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 220 LB