MAUDE Adverse Event Report: Datascope Corp. TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0608
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Other
Event or Problem Description
It was reported that during preparation for insertion of a transray plus 40cc intra-aortic balloon (iab) catheter, negative pressure was maintained on the balloon using the supplied one-way valve and a 30 ml syringe while a manual flush was performed through the guidewire inner lumen.During the flush, flushing solution was observed leaking into the balloon interior.The event occurred before the iab catheter was fully inserted into the patient.The affected catheter was not used, and iabp therapy was successfully completed using another new transray plus 40cc catheter.The intended insertion site was the right femoral artery, and the aortic condition was reported as normal.The guidewire was manufactured by getinge; the dilator and sheath were manufactured by another company.No patient harm was reported.
Additional Manufacturer Narrative
Updated field: h2, g6, h11, b5, b6, a1, d9, h3.Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: TRANS-RAY PLUS 7.5Fr 40cc 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: 50251829
• Report Number: 2248146-2026-0001401
• Device Sequence Number: 10169495
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• UDI-Public: (01)10607567111728(17)280611(10)3000482523(11)250611
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 0684-00-0608
• Device Catalogue Number: 0684-00-0608
• Device Lot Number: 3000482523
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown