MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-01
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	03/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1 initial reporter: (b)(6).Another contact info: (b)(6).The customer reported via the emergency support program that the sensation plus 50cc displayed a fiber optic (fo) sensor failure alarm during use.The nurse confirmed there was no kink or fold in the fo cable and had already unplugged and reconnected it once.Esp personnel guided her to repeat the reconnection, confirming proper arrow to arrow alignment, and then instructed her to transition from fo to transducer pressure monitoring.The fo cable was coiled, taped, and labeled as fiber optic sensor failure, do not use.Limited complaint details were obtained as the nurse declined further information.No patient harm or injury was reported.
Event or Problem Description
It was reported by the customer through emergency support program that sensation plus 50cc had fiber optic (fo) sensor failure alarm 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.Esp personnel asked her to repeat the step, verifying that it was arrow to arrow and seated appropriately.Esp personnel 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.Minimal complaint information obtained as nurse did not wish to retrieve all the information.She was appreciative of the support and denied any additional needs.No harm or injury to the patient was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 (medical device problem code), d10.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
• 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: 24895176
• Report Number: 2248146-2026-0000912
• Device Sequence Number: 15712508
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000513355(17)281112(11)251112
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• 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): 05/08/2026

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: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3000513355
• 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: 03/28/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: 56 YR
• Patient Sex: Female