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	Difficult to Insert (1316); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that resistance was encountered during the insertion of the trans ray plus 40cc balloon, which hindered smooth advancement.Out of concern for potential balloon damaged, the device was replaced with another balloon of identical specification.The subsequent balloon was inserted smoothly without resistance.No alarms were activated and no patient injury or harm was reported.
Additional Manufacturer Narrative
Due to characterization limit e1 initial reporter: (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Event site postal code: (b)(6).The correction of e1 initial reporter deems required.This is based on the internal evaluation.Previous initial reporter: (b)(6).Corrected initial reporter: (b)(6).An iabp was used for cardiac support in a man in his 70s following catheterization.During insertion, significant resistance was encountered with a trans ray plus 40 cc balloon, raising concern for potential balloon damage.As a precaution, the balloon was removed and replaced with a new balloon of the same size, which was inserted without difficulty.No alarms occurred, and the patient experienced no adverse effects.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.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.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d4 (lot and udi), h6 (medical device problem code, type of investigation, investigation findings and investigation conclusions).

• 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: 24758961
• Report Number: 2248146-2026-0000833
• Device Sequence Number: 8707758
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• UDI-Public: (01)10607567111728(17)280123(10)3000446051(11)250123
• 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): 05/07/2026

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: 3000446051
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 05/07/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/30/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male