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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion of transray plus 40cc intra-aortic balloon (iab) catheter malfunctioned.The balloon passed through the sheath, but could not be advanced further from around the area just proximal to the abdominal aorta.After replacing it with a new balloon catheter (trp4046), the catheter was inserted without any issues.No harm to the patient was reported.Due to patient's pre-existing infection, unrelated to the getinge device, the iab was not saved.
Additional Manufacturer Narrative
E.Initial reporter: event site name: (b)(6).The serial number for the medical device referred to in this medical device report has not been received.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: 50865229
• Report Number: 2248146-2026-0001560
• Device Sequence Number: 13067324
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 0684-00-0608
• Device Catalogue Number: 0684-00-0608
• Device Lot Number: 3000464531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown