MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB W/ ACCESSORIES (W/O STATLOCK)(CHINA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-05
Medical Device Problem Codes	Restricted Flow rate (1248); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that during use the sensation plus 40cc intra-aortic balloon (iab) had a fiber optic sensor failure alarm.No harm reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields b4 d9 g3 g6 h2 h3 h6 type of investigation findings component codes investigation conclusions h11 additional initial reporter names abi erikacorrected field b5 g2 h6 medical device problem code no decon or visual inspection performed since product was not returned and could not be evaluatedthe complaint describes a series of events between october 19 and november 4 2025 involving alarms and handling issues with an intraaortic balloon iab catheter during patient care and transfer on october 20 a ccu nurse reported a single iab catheter restriction alarm which cleared after troubleshooting with no signs of blood discoloration kinking or patient harm getinge support advised repositioning and dressing adjustments after the patient transferred to corewell health staff discovered that a flowtrac monitoring line had been incorrectly attached to the iab catheters inner lumen which was promptly removed getinge reinforced that only a fluidfilled pressurized transducer system should be used a biohazard kit originally intended for the first facility was redirected due to the transfer separately on november 4 a bronson icu nurse reported a fiber optic sensor failure alarm reseating the fiber optic cable did not resolve the issue so the team successfully transduced the inner lumen as the arterial source using compatible tubing surveillance information was collected and the catheter was requested for return no patient harm was reported in any of the interactionsbased on the event description the most likely root cause is improper or incompatible equipment handling and monitoring setup during patient care and interfacility transfer including the incorrect attachment of flowtrac tubing to the iab catheter inner lumen and challenges with fiber optic connections suggesting gaps in familiarity with the correct iab monitoring configuration and variability in handling across multiple clinical teams it is impossible to determine the root cause of the sensor failure since the product was not returned for evaluation the failure mode is addressed in the risk file and is operating within its risk profile the ifu addresses the reported failure there were no ncmrs identified which could cause or contribute to the reported failure the investigation does not indicate that the device was inadvertently released as nonconforming or an adulterated product or was a counterfeit the complaint history review did not identify an adverse trend increase in number of complaints over past three 3 months based on the rational provided above no escalation to the capa process is required.
Event or Problem Description
The complaint was received through a direct call from the customer to the emergency support program.No harm or injury to the patient was reported.It was reported by customer that during use the sensation plus 40cc intra-aortic balloon (iab) had a fiber optic sensor failure alarm and an iab catheter restriction alarm.
Additional Manufacturer Narrative
(additional initial reporter - abi).Updated fields - b4, e1, g3, g6, h2, h6 (health effect ¿ clinical code), h11.Corrected field - d10, h6(type of investigation, component code).

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB W/ ACCESSORIES (W/O STATLOCK)(CHINA)
• 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: 23497356
• Report Number: 2248146-2025-0000710
• Device Sequence Number: 18418644
• Product Code: DSP
• UDI-Device Identifier: 10607567109442
• UDI-Public: (01)10607567109442(10)3000478158(17)280527(11)250527
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• 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): 02/07/2026

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: 0684-00-0568-05
• Device Catalogue Number: 0684-00-0568-05
• Device Lot Number: 3000478158
• 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: 10/19/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 02/07/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/30/2026; 02/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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: PUMP
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 94 KG