MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0469-01
Medical Device Problem Codes	Failure to Sense (1559); Obstruction of Flow (2423); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11 corrected fileld - h6 (investigation conclusions).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Due to character limit in the e1 section: the full initial reporter's name is (b)(6).The full event site name is (b)(6).The additional initial reporter's name is (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
User called into emergency support program line to request support with a fiber optic sensor failure alarm on intra aortic balloon and cardiosave pump.The patient was just shifted from cardiac surgery and the reported alarm started occuring after transfer of patient.The troubleshooting was suggested by esp representative like disconnecting and reconnecting fiber optic cable and verifying it was seated properly.The pressure source was shifted from fiber optic cable to transducer.No harm or injury was reported.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.Corrected fields: d4 serial number should have kept empty, d7a, e1 initial reporter name, e3, g2.The complaint was received through a direct call from the customer to the emergency support program.Nurse called for assistance with a fiber-optic sensor failure alarm on a cardiosave during use, no patient harm or injury was reported.Nurse stated that the patient had just arrived at the unit form a cardiac surgery and the or reported the alarm started after moving the patient from the or table to the bed.Esp team member asked her to disconnect the fo cable and reconnect, verifying that it was arrow to arrow and seated appropriately.Esp team member then reviewed the steps to transition from fo to transducer as the pressure source and requested she coil, tape and label the fo cable as ¿fiber-optic sensor failure.Do not use.¿ complaint information obtained.Unfortunately, the or had not set up the inner lumen to a pressurized setup and nurse was unable to transduce the inner lumen.Esp team member encouraged her to notify the attending of the fo sensor failure and label the inner lumen as ¿clotted inner lumen, do not flush or use.¿ esp team member encouraged latrice to use an alternate arterial source for therapy while notifying the provider.She agreed to the plan and was appreciative of the support and denied any additional needs.
Event or Problem Description
N/a.

• Brand Name: SENSATION 7FR. 34CC IAB
• 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: 23486673
• Report Number: 2248146-2025-0000703
• Device Sequence Number: 21454651
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(10)3000451542(17)280213(11)250213
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0469-01
• Device Lot Number: 3000451542
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 01/22/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/21/2026; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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 PUMP.
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 85 KG