MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-01
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported through a direct call from the customer to the emergency support program that, intra-aortic balloon (iab) that the position of the balloon (radiopaque tip was below the 5th intercoastal space.The alleged issue was not related to a device malfunction, rather user error (malposition of balloon).
Additional Manufacturer Narrative
Updated field: b4, b5, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.Corrected fields: g2, h5.No decon or visual inspection performed since product was not returned and could not be evaluated.A complaint was received through a direct call to the emergency support program.(b)(6), an icu rn, sought confirmation about low augmentation readings in a patient with an intra aortic balloon (iab).An initial chest x ray indicated the balloon was positioned 7 cm below the aortic arch.After the physician repositioned it, a follow up x ray shared via screenshot still showed the radiopaque tip positioned below the 5th intercostal space, confirming continued malposition.The balloon pump¿s performance (low augmentation and unchanged numbers) was consistent with this incorrect placement.The support specialist explained that only proper balloon positioning would resolve the issue.(b)(6) appreciated the clarification and received the direct support number for future questions.No patient harm was reported.Based on the event description, the balloon¿s radiopaque marker remained too low (below the 5th intercostal space), preventing optimal function.Device performance was appropriate for its incorrect placement, and no device malfunction was indicated.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
It was reported through a direct call to the emergency support program.(b)(6) an icu rn, sought confirmation about low augmentation readings in a patient with an intra aortic balloon (iab).An initial chest x ray indicated the balloon was positioned 7 cm below the aortic arch.After the physician repositioned it, a follow up x ray shared via screenshot still showed the radiopaque tip positioned below the 5th intercostal space, confirming continued malposition.The balloon pump¿s performance (low augmentation and unchanged numbers) was consistent with this incorrect placement.The support specialist explained that only proper balloon positioning would resolve the issue.(b)(6) appreciated the clarification and received the direct support number for future questions.No patient harm was reported.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES
• 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: 23903389
• Report Number: 2248146-2025-0000877
• Device Sequence Number: 12019285
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000425585(17)271018(11)241018
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 02/10/2026

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: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0568-01
• Device Lot Number: 3000425585
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/28/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• 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: UNKNOWN.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG