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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
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
The complaint was received through a direct call from the customer (registered nurse) to the emergency support program.It was reported that while using sensation plus 7.5fr 40cc intra-aortic balloon (iab), the patient with an axillary balloon.They¿ve been following their forward flow policy and flushing every 4 hours, but they¿re losing the inner lumen again on a line on the blood pressure.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected field - d10, h6 (type of investigation).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6(type of investigation, investigation findings, component code, conclusion), h11.A clinical nurse specialist called regarding the use of thrombolytic agents in the inner lumen of a sensation plus catheter currently in use.She reported that the patient had an axillary balloon and had undergone multiple iab exchanges with the most recent balloon placed and connected to a cardiosave hybrid system.Despite following flushing protocols the inner lumen was repeatedly occluding and the attending was considering using alteplase.Troubleshooting confirmed multiple prior exchanges and that thrombolytic use was not recommended based on previous guidance and off label disclaimers were provided.The nurse requested written confirmation of these recommendations to share with the attending and provided the required complaint information.The request was reviewed with medical affairs and arrangements were made to send a returned catheter kit for further evaluation.

• 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: 24637678
• Report Number: 2248146-2026-0000788
• Device Sequence Number: 10008816
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000514254(17)281118(11)251118
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 04/10/2026

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: 3000514254
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 04/10/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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.; UNKNOWN.
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 126 KG