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

Model Number	0684-00-0480-01
Medical Device Problem Codes	Pacing Problem (1439); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer (registered nurse) through emergency support program that while using linear 7.5fr.40cc iab intra aortic balloon (iab), does not have an ap on the screen.Attempts at aspiration and flush in standby reveals that the inner lumen is clotted.No harm or injury to the patient was reported.
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, component code, investigation conclusions), h11.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.Nurse called from the icu stating she does not have an ap on the screen any longer.Attempts at aspiration and flush in standby reveals that the inner lumen is cotted.Esp team member reviewed alternate sources of the ap waveform.Nurse and staff chose to connect the patients¿ radial arteria transduced line to the cs300 for monitoring.Nurse does not wish to give any information for product return or patient identification.She states there was no interruption of therapy and no harm to patient.She then asks some general pump management questions, and all are answered to her satisfaction.
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 40CC 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: 24017700
• Report Number: 2248146-2026-0000159
• Device Sequence Number: 15691592
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• 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): 02/07/2026

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: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/07/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CS300
• Patient Sex: Unknown