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

Model Number	0684-00-0470-07
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was initiated on intra aortic balloon pump (iabp) support with 40 cc sensation balloon catheter.After insertion and connection to the iabp console, no arterial pressure signal was detected from iab.A persistent iab optical sensor failure alarm indicated malfunction of the fiber optic pressure sensing system.Iabp support was continued in ecg trigger mode using the same balloon catheter to maintain synchronization with the cardiac cycle.Arterial blood pressure was monitored via an alternate invasive arterial line connected to the bedside monitor.No harm was reported.
Additional Manufacturer Narrative
(b)(6).As the balloon was not returned for evaluation, so an exact cause of the issue could not be identified.However, based on our investigation, a sensor failure can occur due to one or more of the following probable causes: optical sensor kink ,break in sensor or connector issue.

• Brand Name: SENSATION 7FR. 40CC IAB (INDIA)
• 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: 24983119
• Report Number: 2248146-2026-0000949
• Device Sequence Number: 9642401
• Product Code: DSP
• UDI-Device Identifier: 10607567109749
• UDI-Public: (01)10607567109749(10)3000356102(17)270119(11)240119
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: 0684-00-0470-07
• Device Catalogue Number: 0684-00-0470-07
• Device Lot Number: 3000356102
• 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: 04/04/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• 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: CS300 AND CARDIOSAVE
• Patient Sex: Male
• Patient Weight: 65 KG