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 Recalibrate (1517); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id (b)(4).
Event or Problem Description
It was reported that during intra aortic balloon (iab) therapy there were intermittent reading showing diastole to be zero, customer tried to re-calibrate the pressure but still the same.Asked them to take off the fibre optic sensor, use their own transducer, the problem was solved.User suspects problem for the fibre optic sensor, now the goods will be sent back for further investigation.There was no patient harm or injury reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusion), h11.The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The one-way valve, extender and pressure tubing were also returned.A sensor output test was performed and the sensor was found to be within specification.The reported events cannot be confirmed by the evaluation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.The device meets all product specifications.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 non-conforming 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.

• 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.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 23001572
• Report Number: 2248146-2025-0000531
• Device Sequence Number: 15725741
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000336045(17)260927(11)230927
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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 Expiration Date: 09/27/2026
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000336045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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 HYBRID.
• Patient Sex: Unknown