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); Difficult to Remove (1528); Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Unspecified Vascular Problem (4441); Insufficient Information (4580)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during use of a trans-ray plus 7.5fr 40cc intra-aortic balloon (iab) catheter connected to a cardiosave intra-aortic balloon pump (iabp), blood was observed in the helium extender tubing.An attempt to remove the intra-aortic balloon (iab) catheter was unsuccessful due to resistance, and the catheter was subsequently removed surgically by the vascular surgery team.It was reported that thrombus formation within the balloon was suspected to have prevented catheter removal.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Event site name: (b)(6).Event site postal code: (b)(6).This event contains both an adverse event and a product problem.Due to a temporary system limitation associated with recent fda emdr system enhancements, only the adverse event designation could be transmitted in the current submission.Product problem details are included within this report.A supplemental mdr will be submitted once the emdr utility has been updated to support transmission of both event classifications.The serial number for the medical device referred to in this medical device report has not been received, and therefore, no udi number can be provided.Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Updated fields: b4, d9 (return to manufacture date), g3, g4 (pma 510k), g6, g7, h2, h3, h4, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.Corrected fields: d4 (lot, exp date and udi), d8 (revert this field to blank, as it was inadvertently submitted initially), e1 (event site address), h6 (medical device problem code).The iab was returned with the membrane and inner lumen cut in three parts with blood on the interior and exterior of the catheter and between the catheter and the sheath.The extender tubing was also returned.An underwater leak test of the balloon, catheter, y fitting, extracorporeal and extender tubing was performed and no leaks were detected.Blood filling inside the membrane may result in difficulty removing the iab from the patient.However we were unable to conclusively determine the presence of a leak on the iab due to the returned condition of the iab as we were unable to fully evaluate the iab.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.

• 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: 50405557
• Report Number: 2248146-2026-0001440
• Device Sequence Number: 10444206
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• 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): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0608
• Device Catalogue Number: 0684-00-0608
• Device Lot Number: 3000484001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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 IABP; CARDIOSAVE IABP OT1583306.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown