MAUDE Adverse Event Report: Datascope Corp. TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0607
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of transray plus 35cc balloon catheter a blood clot was observed inside the gas tubing; therefore, the balloon was removed.As the patient's condition had improved, therapy was discontinued without replacing the balloon catheter with a new one.No adverse effect on the patient was reported.
Additional Manufacturer Narrative
Event site postal code: 830-0033 upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: TRANS-RAY PLUS 7.5Fr 35cc IAB WITH 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: 50751086
• Report Number: 2248146-2026-0001526
• Device Sequence Number: 20944833
• Product Code: DSP
• UDI-Device Identifier: 10607567111711
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 0684-00-0607
• Device Catalogue Number: 0684-00-0607
• Device Lot Number: 3000487713
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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 (b)(4)
• Patient Sex: Unknown