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 Codes	Inflation Problem (1310); Leak/Splash (1354); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) rn called into the emergency support program line to request support for review of an auto r wave deflate notification on the cardiosave during use.When asked whether any additional alarms had been present recently (b)(6) stated that a gas loss alarm and an augmentation below set limit alarm had also occurred.She requested review of possible reasons for all alarms.(b)(6) stated she had verified no blood in the helium tubing and that all connections were secure.She stated that the patient was intubated and on a peep of 10 on multiple medication drips and that the pump was currently providing therapy.Esp personnel reviewed possible clinical scenarios that could cause the alarms and walked her through use of the iab fill and start keys to restart therapy should a gas loss alarm occur again.Upon completion of the review and troubleshooting an unable to update timing alarm sounded.(b)(6) stated the patient had a fiber optic catheter in place and that it was being transduced.She stated the fo ap was the current source of arterial pressure on the cardiosave.Esp personnel instructed her to recalibrate the fiber optic sensor however, this did not improve ap quality.Esp personnel had (b)(6) take pictures of the cardiosave and send them for review of therapy timing and all waveforms.After reviewing the images esp personnel instructed her to aspirate and flush the inner lumen with the pump on standby for 15 seconds.After flushing the inner lumen the ap waveform became clearer and more distinct resolving the unable to update timing message.Esp personnel reminded (b)(6) to perform frequent flushing of the inner lumen per hospital protocol and to ensure an x ray is reviewed for proper placement of the iab.Esp personnel also reinforced that she should always ensure there is no blood or discoloration in the helium extender tubing prior to resuming therapy.(b)(6) thanked esp personnel for the assistance and provided complaint information.
Additional Manufacturer Narrative
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, h11.After further review, an initial emdr for this complaint was incorrectly submitted.This is a non-reportable event, making it non-reportable to the fda.As a result, no follow up emdr is necessary.Please cancel this report 2248146-2026-0000860 in your database.

• 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: 24799343
• Report Number: 2248146-2026-0000860
• Device Sequence Number: 15837257
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000448003(17)280124(11)250124
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/10/2026

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
• Device Lot Number: 3000448003
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 95 KG