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 Codes	Restricted Flow rate (1248); Pacing Problem (1439); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: due to characterization limit e1 (event site full name: (b)(6)).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 id# (b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the blood pressure numbers from balloon pump and bedside monitor were so different.No patient harm or injury was reported.
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 that during intra-aortic balloon (iab) therapy, the blood pressure numbers from balloon pump and bedside monitor were so different.Complaint information obtained.We also discussed the quality of balloon waveform which was indicative of possible kink or restriction somewhere in the helium pathway, but she denied any visualized restriction.(b)(6) texted me at 4:47 pm est informing the bedside provider was unable to attempt to aspirate due to other urgent needs in the unit.
Additional Manufacturer Narrative
Updated fields - b4, d4 expiry date, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected field: b5, d3, d4 serial number should be left empty, udi number, g2.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.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.

• 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: 23672264
• Report Number: 2248146-2025-0000796
• Device Sequence Number: 15948516
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(10)3000497977(17)280918(11)250918
• Combination Product (Y/N): N
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 3000497977
• 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: 11/08/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 54 KG