MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1, event site name is (b)(6) hospital.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that via a direct call from the customer to the emergency support program for assistance with a fiber-optic sensor failure alarm on a cardiosave during use.Nurse denied any kink or fold in the fo cable and stated that she had already unplugged and re plugged the fo sensor cable once before.Nurse was asked to repeat the step, verifying that it was arrow to arrow and seated appropriately and reviewed the steps to transition from fo to transducer as the pressure source and requested to nurse to label the coil, tape and label the fo cable as ¿fiber-optic sensor failure.Do not use.Patient was involved.No harm.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.Corrected field: e1 initial reporter name (initially contact person name was mentioned as initial reporter incorrectly), g2, h6 medical device problem code.It was reported that via a direct call from the customer to the emergency support program for assistance with a fiber-optic sensor failure alarm on a cardiosave during use.Nurse denied any kink or fold in the fo cable and stated that she had already unplugged and re plugged the fo sensor cable once before.Nurse was asked to repeat the step, verifying that it was arrow to arrow and seated appropriately and reviewed the steps to transition from fo to transducer as the pressure source and requested to nurse to label the coil, tape and label the fo cable as ¿fiber-optic sensor failure.Do not use.
Additional Manufacturer Narrative
Updated fields - b4, g2, g3, g6, h2, h3, h6 (component code, investigation conclusions).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (health effect ¿ clinical code), h11.Corrected field - h6(component code).
Additional Manufacturer Narrative
Additional initial reporter -(b)(6).Updated fields - b4, e1, g3, g6, h2, h6(health effect ¿ clinical code), h11.Corrected field -g2, h6 (investigation findings, component code, investigation conclusions).

• Brand Name: SENSATION 7FR. 40CC 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: 23445346
• Report Number: 2248146-2025-0000678
• Device Sequence Number: 13013698
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000450286(17)280205(11)250205
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 12/29/2025

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: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000450286
• 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: 10/12/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 12/29/2025; 12/29/2025; 12/29/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/26/2025; 12/29/2025; 12/29/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 79 KG