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 Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that, while using the trans-ray plus 7.5fr 35cc intra-aortic balloon pump (iabp), a sensor malfunction prevented its use, and the catheter had to be replaced.No harm or injury to the patient was reported.

• 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: 24869525
• Report Number: 2248146-2026-0000895
• Device Sequence Number: 9946691
• Product Code: DSP
• UDI-Device Identifier: 10607567111711
• UDI-Public: (01)10607567111711(17)280326(10)3000464246(11)250326
• 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): 05/15/2026

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: 3000464246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/24/2026; 05/15/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/15/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male