MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB W/ ACCESSORIES (W/O STATLOCK)(CHINA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-05
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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
It was reported by the customer through emergency support program that the sensation plus 40cc had fiber-optic sensor failure alarm on a cardiosave during use.Nurse denied any kink or fold in the fo cable and stated that he had already unplugged and re plugged the fo sensor cable once before.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Other contact phone number: (b)(6).Updated field: b4, g3, g6, h2, h4, h6(type of investigation, investigation findings, investigation conclusions), h11.Corrected field: d4 udi number.Matthew, a ccu rn, called into emergency support program line for assistance with a fiber-optic sensor failure alarm on a cardiosave during use.Matthew denied any kink or fold in the fo cable and stated that he had already unplugged and re plugged the fo sensor cable once before.Esp team asked to repeat the step, verifying that it was arrow to arrow and seated appropriately.There was no patient harm or injury reported.
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB W/ ACCESSORIES (W/O STATLOCK)(CHINA)
• 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: 24128063
• Report Number: 2248146-2026-0000456
• Device Sequence Number: 5430663
• Product Code: DSP
• UDI-Device Identifier: 10607567109442
• UDI-Public: (01)10607567109442(10)3000478158(17)280527(11)250527
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/11/2026

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: 0684-00-0568-05
• Device Catalogue Number: 0684-00-0568-05
• Device Lot Number: 3000478158
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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 Sex: Unknown