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 Codes	Signal Artifact/Noise (1036); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please revert the a1 (patient id) a3 d8 to blank updated fields- b1, b4, d9, d10, g3, g4, g6, g7, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11 the iab was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender and pressure tubing were also returned.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y fitting, extracorporeal, extender and pressure tubing was performed and a leak was detected on the membrane approximately 1.5cm from the rear seal measuring 0.025cm in length.The reported difficult unable to monitor waveform pressure cannot be confirmed by the evaluation.The reported leak was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.
Event or Problem Description
N/a.

• 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: 50539970
• Report Number: 2248146-2026-0001489
• Device Sequence Number: 9432403
• Product Code: DSP
• UDI-Device Identifier: 10607567111711
• UDI-Public: (01)10607567111711(17)280115(10)3000445579(11)250115
• 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): 09/01/2026

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: 3000445579
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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