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	Leak/Splash (1354); Increase in Pressure (1491); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1 event site name is (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).
Event or Problem Description
It was reported by the customer via emergency support program line, that intra-aortic balloon (iab) sensation plus 40cc experienced intermittent gas loss and gas gain alarms during use.There were no patient harm or injury reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.Corrected fields: d10, g2, h6 (medical device ¿ problem code).(b)(6), an rn in the cticu, contacted emergency support regarding intermittent gas loss and gas gain alarms on the iabp.He reported that a gas loss alarm had occurred earlier, which was resolved; however, a short time later, the pump began alarming for gas gain.At the time of the call, the pump was set to a 1:3 assist ratio, with a plan to remove the balloon later in the day.Tony stated that the pump continued to alarm intermittently.Tony inquired if any additional troubleshooting steps were recommended.I verified that there was no blood present in the helium tubing and confirmed that the iab fill key was used each time the alarm occurred.I advised either changing the pump or continuing with the same troubleshooting measures until balloon removal.The nature of the alarm and possible clinical causes were reviewed; however, no obvious clinical explanation for the alarms was identified.Gas loss alarm triggered when helium loss is greater than 5 cc per hour due to leak or diffusion.Activation: inflation equal to or greater than 80 milliseconds, deflation equal to or greater than 250 milliseconds.Primary cause: patient condition (febrile, tachycardic).Gas gain alarm.Triggered when helium gain exceeds 5 cc relative to the last autofill.Same activation conditions.Primary cause: catheter occlusion/restriction.System response: both alarms cause venting and iab deflation; occur in all modes.Mitigation: if no leaks, occlusions, or contraindicated conditions are present, then perform a manual iab fill to purge helium and recalibrate the system.Fill key: press 2 sec to initiate autofill; resets 2-hour timer.Contraindications (per ifu): severe aortic insufficiency, aneurysm, advanced calcific disease, significant vascular disease, severe obesity/groin scarring (avoid sheathless insertion).

• 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: 23903365
• Report Number: 2248146-2025-0000879
• Device Sequence Number: 12019284
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/28/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; PUMP
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 82 KG