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	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (type of investigation), h11.A fiber optic sensor failure in an intra aortic balloon occurs when the pressure sensor in the catheter fails to transmit real time aortic pressure signals to the iabp console.This affects proper timing of balloon inflation and deflation.After catheter insertion no optical sensor pressure was detected and an iab optical sensor malfunction alarm was triggered.The device module was checked and found to be functioning normally.A catheter side optical sensor defect was suspected so the catheter was replaced with a 35cc catheter of the same size.Patient information has not been disclosed in accordance with hospital policy.
Event or Problem Description
N/a.
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 during use, the transray plus 35cc intra aortic balloon (iab) malfunctioned."iab optical sensor malfunction" alarm displayed.There were no patient harm or injury 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: 24555357
• Report Number: 2248146-2026-0000757
• Device Sequence Number: 18357958
• Product Code: DSP
• UDI-Device Identifier: 10607567111711
• UDI-Public: (01)10607567111711(17)280718(10)3000491604(11)250718
• 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
• Report Date (Section B): 03/24/2026

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: 3000491604
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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: UNKNOWN.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 60 KG