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	Pressure Problem (3012); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation, below field are added from e.1.: event site name: (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 through a direct call from the customer to the emergency support program that, intra-aortic balloon (iab) had supraoptimal augmentation.There was no patient harm.
Additional Manufacturer Narrative
Updated fields: b4, d9 (device available for eval), g3, g6, h2.H3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: d4 (unique identifier (udi) #, d10, g2, h6 (component codes).No decon or visual inspection performed since product was not returned and could not be evaluated.A cardiology fellow, melis, contacted emergency support after a nurse reported concerns about the arterial waveform and potential timing issues.Review of the provided screenshots including the printed strip and pump data showed normal inflation deflation timing and appropriate hemodynamic values.However, the augmentation was noted to be higher than expected.A chest x ray was recommended to confirm catheter placement.The x ray image revealed the catheter¿s radiopaque tip positioned at the lower end of the 4th intercostal space, indicating a low placement.The proper recommended position is between the 2nd and 3rd intercostal spaces.This information was communicated to melis, who appreciated the guidance.Product surveillance information could not be fully collected because melis was not near a computer.Since the product was not returned, we were unable to perform a device evaluation.Based on the event description, improper intra aortic balloon catheter positioning (low catheter placement at the 4th intercostal space instead of the recommended 2nd 3rd intercostal space).This malposition likely contributed to the waveform concerns and supraoptimal augmentation noted by the clinical team.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.

• 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: 23903401
• Report Number: 2248146-2025-0000882
• Device Sequence Number: 5029580
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000411228(17)270814(11)240814
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 3000411228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/28/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• 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: PUMP
• Patient Age: 71 YR
• Patient Sex: Female