MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0469-01
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Dr (b)(6), a resident in the cicu, called the emergency support program line to request support regarding the augmentation being lower than expected.He explained that the patient originally had a femoral balloon, which was later exchanged for an axillary balloon.The esp team provided him with the axillary disclaimer and reviewed screenshots showing appropriate waveforms and numbers, with the augmentation being close to the systolic pressure.It was explained that the change in augmentation was due to the axillary insertion with its upside-down orientation and the smaller balloon size compared to the previous 50 cc femoral balloon, rather than any device malfunction.No patient harm or injury was noted.
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.Complaint record id (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (type of investigation, investigation findings and investigation conclusions), h11.Corrected field: d10.No decon or visual inspection performed since product was not returned and could not be evaluated.Dr.Shah, a cicu resident, contacted support regarding lower-than-expected augmentation after a patient¿s intra-aortic balloon pump was exchanged from a femoral balloon to an axillary balloon the previous evening.The axillary balloon disclaimer was reviewed with him.Screenshot review confirmed appropriate waveforms and values, with augmentation near systolic pressure.Balloon position was verified as correct.Dr.Shah was unsure of the patient¿s prior augmentation values.It was explained that axillary balloons are positioned upside down and therefore measure distal aortic pressure rather than ascending aortic pressure, which affects observed augmentation.Additionally, the current balloon was a 34 cc device, whereas the prior femoral balloon had been 50 cc, which also impacts augmentation magnitude.Product surveillance information was collected.Dr.Shah expressed appreciation for the clarification and support.Chance ingle and bradley nixon were notified via email.Since the product was not returned, we were unable to evaluate the device.Based on the description, the lower-than-expected augmentation was attributed to expected physiologic and device-related differences following the conversion from a femoral to an axillary intra-aortic balloon pump.The axillary balloon is positioned in a reversed orientation, resulting in pressure measurements from the distal aorta rather than the ascending aorta, which naturally produces lower observed augmentation values.Additionally, the patient¿s balloon size was reduced from a 50 cc femoral balloon to a 34 cc axillary balloon, further contributing to decreased augmentation.No evidence of device malfunction or improper balloon positioning was identified, and waveforms and pressures were confirmed to be appropriate for the axillary configuration.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 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.
Event or Problem Description
N/a.

• Brand Name: SENSATION 7FR. 34CC 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.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 24599880
• Report Number: 2248146-2026-0000766
• Device Sequence Number: 15854560
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(10)3000371514(17)270301(11)240301
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0469-01
• Device Lot Number: 3000371514
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/14/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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: PUMP
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 92 KG