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	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that while using trans-ray plus 7.5fr 40cc (iab) the blood pressure signal from the optical sensor temporarily disappeared, and the waveform reappeared.There was no manual intervention during the disappearance and reappearance.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Due to characterization limit e1: event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Other contact phone number: (b)(6).Updated field: b4, d3, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11 the iab was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The y-fitting¿s serial number was obscured by a black mark, making it unreadable.A kink was observed on the catheter tubing and inner lumen approximately 57.4cm from iab tip.A second kink was observed on the catheter tubing near the y-fitting approximately 73.9cm from iab tip.The inner lumen was found occluded with dried blood.The occlusion was able to be cleared.A sensor output test was performed and the sensor was found to be within specification.The reported event cannot be confirmed by the evaluation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.All failure modes related to balloon malfunction are addressed in the risk file and there individual complaint occurrence rates are within its risk profile.The ifu addresses the mitigations for all balloon failures.Each iab manufactured is 100 percent inspected and the controls put in place during the manufacturing of the iab would catch a defect and not allow non-conforming device to be released.The iab catheter is unknown based on the rational provided above, no escalation to the capa process is 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: 24518120
• Report Number: 2248146-2026-0000748
• Device Sequence Number: 8514635
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• UDI-Public: (01)10607567111728(17)280915(10)3000500916(11)250915
• 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,Followup
• Report Date (Section B): 05/14/2026

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: 0684-00-0608
• Device Lot Number: 3000500916
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/22/2026; 04/21/2026; 05/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/25/2026; 05/01/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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