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	12/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Event or Problem Description
It was reported by the customer through emergency support program that the sensation plus 40cc had iab migration issue.Registered nurse (rn), called requesting assistance for a balloon catheter placement.Nurse stated, ¿it looks like it is not in the right place or in between the second and third intercostal space¿.A screenshot of the chest xray revealed the distal marker was in between the 5th and 6th intercostal space.She reported the augmentation was 156 and the assisted systolic pressure was 150 with a map consistently in the 120s.She stated the patient was not currently on any iv medications and the plan was for the patient to be transferred today or tomorrow with the iab in place for a cabg.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Event site postal code: (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 record id (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (type of investigation, investigation findings and investigation conclusions), h11 corrected fields: d4 (udi) based on the description, right after inserting the transray plus 35cc, an optical sensor malfunction occurred.The team switched to central lumen transducer monitoring for the remainder of use.There was no patient harm, no delays, and no extra treatment.Patient details were not provided, and the product will be recalled.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 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: 24092085
• Report Number: 2248146-2026-0000352
• Device Sequence Number: 10259059
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000490853(17)280715(11)250715
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 3000490853
• 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: 12/27/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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: UNKNOWN.
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 77 KG