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 Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
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 on 31 august at 14:00, a transray plus 40cc intra-aortic balloon (iab) catheter was inserted and intra-aortic balloon pump (iabp) support was initiated.The catheter was inserted via the right femoral artery.On 1 september at 9:30 am, an ¿iab circuit leak¿ alarm occurred.After removing the extension tube, a syringe was attached to the extracorporeal tubing and negative pressure was applied.Blood backflow was observed, and the event was therefore determined to be a balloon rupture.No blood backflow into the cardiosave iabp console was observed.The catheter was immediately removed.As the patient's hemodynamics remained stable, iabp therapy was discontinued at that point.No harm to the patient was reported.It was reported that the ¿gas loss in iab circuit¿ alarm was also displayed on the cardiosave iabp.
Additional Manufacturer Narrative
E.Initial reporter (b)(6).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: 50865620
• Report Number: 2248146-2026-0001561
• Device Sequence Number: 21177070
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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: 3000378298
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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 IABP OT#(b)(4)
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 182 LB