MAUDE Adverse Event Report: Datascope Corp. Sensation Plus 8Fr. 50cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0576-01U
Medical Device Problem Codes	Failure to Calibrate (2440); Device Sensing Problem (2917); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an emergency support program call, a cicu rn reported concerns regarding the fiber-optic arterial pressure waveform on a cardiosave intra-aortic balloon pump (iabp) during support with a sensation plus 8fr.50cc intra-aortic balloon (iab).The customer reported that the fiber-optic waveform appeared to contain artifact, with diastolic pressure intermittently decreasing to 0 or the teens and augmentation decreasing; the patient was reported to be in normal sinus rhythm without ectopy.A chest x-ray had been obtained, and the provider reported that there appeared to be no change in iab position.Review of the available waveform showed no evidence of damping, and the radiopaque distal marker was positioned between the 4th and 5th intercostal spaces.Recommended iab positioning was reviewed, and the customer was advised to notify the provider.The inner lumen was flushed through the transducer with the pump in standby for approximately 20 seconds, but the waveform remained unchanged after therapy was resumed.An attempt was made to transition to the transducer pressure source for comparison; however, the appropriate interfacing transducer cable was not available.Potential causes of discrepancies and artifact in the fiber-optic arterial pressure waveform were reviewed, and the customer was advised to notify the provider for further evaluation and management.Near the end of the call, an unable to calibrate fiber-optic sensor alarm was reported.The nature of the alarm and the potential relationship between the reported pressure discrepancies and the calibration issue were discussed.The customer was provided with direct contact information for additional assistance.The following day, another bedside team member contacted clinical support regarding the same patient and catheter, and a fiber-optic sensor failure message was reported.Complaint information was obtained.A return catheter kit was requested for evaluation.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: Sensation Plus 8Fr. 50cc IAB with Accessories, US Only
• 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: 50943271
• Report Number: 2248146-2026-0001586
• Device Sequence Number: 13145265
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Device Lot Number: 3000547188
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2026
• 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 Intra-Aortic Balloon Pump (IABP)
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 281 LB