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	02/12/2026
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that, while using trans-ray plus 7.5fr 40cc intra-aortic balloon pump (iabp), a rupture occurred when the product was inserted using the normal procedure.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated field: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Product was not returned so an exact cause of the issue could not be identified.However, based on our investigation, an intra-aortic balloon (iab) leak is the loss of integrity in the balloon membrane or its connections, allowing blood or gas to enter or escape due to one or more of the following probable causes: 1.User mishandling or not following ifu.2.Membrane folding or resistance.2.Patient-related factors (e.G., plaque abrasion).3.Off-label use.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, conclusion), h11.The iab was returned with the membrane completely unfolded and blood present on both the interior and exterior of the catheter and the extender and pressure tubing were also returned.A kink was noted in the catheter tubing and inner lumen near the y fitting approximately 74.7 cm from the iab tip.An underwater leak test performed on the balloon catheter y fitting extracorporeal extender and pressure tubing revealed a leak at the rear seal of the membrane.The issue was most likely caused by this rear seal leak.Review of the device history record confirmed that the device met all in process and final inspection requirements including two independent production and quality control leak tests one hundred percent rear seal inspection and final functional testing.The investigation found no evidence that the rupture occurred during manufacturing and determined that the rear seal leak most likely occurred after the device was released and outside of manufacturer control with root cause undetermined.The failure mode is addressed in the risk file and remains within the acceptable risk profile and is also covered in the ifu.No nonconformance reports were identified that could have contributed to the issue and the investigation confirmed the device was not nonconforming adulterated or counterfeit.Complaint history review showed no adverse trend and based on these findings no escalation to the capa process was required.
Event or Problem Description
N/a.

• 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: 24504325
• Report Number: 2248146-2026-0000742
• Device Sequence Number: 9942996
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• UDI-Public: (01)10607567111728(17)280318(10)3000461793(11)250318
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 0684-00-608
• Device Lot Number: 3000461793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 05/04/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/26/2026; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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.
• Patient Sex: Unknown