MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1 initial reporter is nicholas fernando/lucy mastej product was not returned so an exact cause of the issue could not be identified.However, based on our investigation, a gas loss can occur due to one or more of the following probable causes.Gas loss in iab circuit a gas loss in the iab circuit takes place when the pump detects a helium loss due to a leak or high rate of diffusion in the iab circuit when a cumulative shuttle gas loss exceeds a nominal 5 cc per hour dynamic limit a gas loss alarm is triggered the alarm activates only when the iab inflation period is greater than or equal to 80 msec and the deflation period is greater than or equal to 250 msec.Causes of gas loss in iab circuit 1 patient condition such as febrile or tachycardic.Gas gain in iab circuit: a gas gain in the iab circuit takes place when a gas gain has been detected in the iab circuit when a cumulative shuttle gas gain exceeds 5 cc relative to the last autofill volume the alarm activates when the iab inflation period is greater than or equal to 80 msec and the deflation period is greater than or equal to 250 msec.
Event or Problem Description
A complaint was received via a direct call to the emergency support program regarding a gas loss alarm on a cardiosave intra aortic balloon pump iabp.No patient injury or adverse outcome was reported.Clinical staff questioned whether the alarm could be related to a potential balloon catheter perforation.Troubleshooting guidance was provided, including assessment for signs of perforation, possible clinical contributors to the alarm, instructions to restart therapy using the iab fill and start keys, and confirmation that the helium extender tubing showed no blood or discoloration prior to resuming therapy.At the bedside, the patient was reported to be non intubated and moving frequently, with visible pulsation at the sheath insertion site.A chest x ray was recommended to verify balloon catheter positioning.Follow up confirmed the x ray showed the balloon catheter was malpositioned and required repositioning.Pump identification and patient information were collected for product surveillance.Catheter identification could not be confirmed due to dressing coverage, though it was noted to be an fo iab, 50 cc, based on extension tubing.The event was internally reported for awareness.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
• 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: 24838909
• Report Number: 2248146-2026-0000870
• Device Sequence Number: 9532249
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• 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
• Report Date (Section B): 04/07/2026

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: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• 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: 03/18/2026
• Initial Report FDA Received Date: 04/10/2026
• 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.
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG