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

Model Number	0684-00-0576-05
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); 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
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.
Event or Problem Description
It was reported by the customer that during the intra-aortic balloon(iab) therapy had an iab issue with fiber optic not working.There was no patient harm reported.
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 event site address, h6 medical device problem code.Additional contact number:(b)(6).Inventory specialist stated that last they had an iab issue with "fiber optic not working".Support team person asked if she could connect support team person with a clinician in the room as the error described is not an existing error for cardiosave.They said she would do some checking but is unsure if anything will be found.She further stated that a new balloon was opened + inserted and worked on the same pump with no further issues.She promised follow-up this week.No patient impact noted.She asked about replacing the balloon but informed me that they did not save the balloon in question.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.Corrected field: h6 medical device problem code.Inventory specialist stated that last they had an iab issue with "fiber optic not working".Support team person asked if she could connect support team person with a clinician in the room as the error described is not an existing error for cardiosave.They said she would do some checking but is unsure if anything will be found.She further stated that a new balloon was opened + inserted and worked on the same pump with no further issues.She promised follow-up this week.No patient impact noted.
Additional Manufacturer Narrative
Updated fields - b4, d2b(product code), d3(manufacturer), g3, g6, h2, h6 (health effect ¿ clinical code), h11.Corrected field - d1(brand name), d4(version or model, catalog, unique identifier (udi).
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 8FR 50CC IAB WITH ACCESSORIES (W/PRESSURE TUBES, NO STYLET, W/O S
• 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: 23551844
• Report Number: 2248146-2025-0000726
• Device Sequence Number: 9457897
• Product Code: DSP
• UDI-Device Identifier: 10607567109381
• UDI-Public: (01)10607567109381(10)3000472788(17)280502(11)250502
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 0684-00-0576-05
• Device Catalogue Number: 0684-00-0576-05
• Device Lot Number: 3000472788
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 01/10/2026; 01/10/2026; 02/10/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/12/2026; 01/13/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• 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