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	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit event site name: (b)(6).As the balloon was not returned for evaluation, the exact cause of the issue could not be identified, however, a broken wire in the optical sensor wiring on the catheter side was suspected.Based on our investigation, the sensor failure may have occurred due to one or more probable causes, including an optical sensor kink, a break in the sensor, or a connector related issue.
Event or Problem Description
It was reported by the customer that immediately after insertion of a trp4046 catheter the optical sensor failed to output pressure, triggering an alarm indicating iab optical sensor malfunction.There was no patient harm and injury reported.

• 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: 25031386
• Report Number: 2248146-2026-0000963
• Device Sequence Number: 21378901
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• UDI-Public: (01)10607567111728(17)260412(10)3000304521(11)230412
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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 Expiration Date: 04/12/2026
• Device Model Number: 0684-00-0608
• Device Catalogue Number: 0684-00-0608
• Device Lot Number: 3000304521
• 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: 04/10/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 62 KG