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	Pacing Problem (1439); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
The customer reported through the emergency support program that the sensation plus 40cc device was experiencing an arterial waveform abnormal, low augmentation issue.An x-ray was taken, but the blurry image showed that the radiopaque marker was not in the correct position.Troubleshooting was conducted with the nurse and confirmed that both the catheter and pump were functioning as intended.No patient harm or injury occurred.The investigation determined that the reported issue was not due to a device malfunction but was caused by user error, specifically the malposition of the balloon catheter.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected field: d10.No decon or visual inspection performed since product was not returned and could not be evaluated.A complaint was received through a direct call to the emergency support program.Devin an icu educator sought assistance after being called to the bedside to evaluate an arterial waveform that appeared abnormal with lower than expected augmentation.A screenshot she provided showed waveform artifact and reduced augmentation.An initial chest x ray was taken but the image was blurry and did not clearly show the radiopaque balloon marker in the expected position between the second and third intercostal space.Troubleshooting confirmed that both the pump and catheter were functioning properly and the issue appeared related to catheter positioning rather than a device malfunction.Devin agreed the balloon did not appear to be in the correct location and planned to repeat the x ray with the pump in standby mode and notify the physician.No patient harm occurred and the user was appreciative of the support provided.Since the product was not returned we were unable to perform a device evaluation.Based on the event description the root cause of the reported issue was improper intra aortic balloon catheter positioning leading to abnormal arterial waveform appearance and reduced augmentation.The device functioned as intended and the observed behavior was consistent with user error due to balloon malposition rather than any malfunction of the pump or catheter.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 months.Based on the rational provided above no escalation to the capa process is required.
Event or Problem Description
N/a.

• 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: 23952949
• Report Number: 2248146-2026-0000029
• Device Sequence Number: 7875288
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000487060(17)280701(11)250701
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 3000487060
• 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: 12/13/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/03/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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: PUMP.; UNKNOWN.
• Patient Sex: Unknown