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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion of the transray plus 35cc catheter shaft kinked and became unusable.There is no information about patient harm.
Additional Manufacturer Narrative
Due to characterization limit e1 initial reporter: (b)(6).Due to characterization limit e1 event site name: (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).
Additional Manufacturer Narrative
Updated fields- b4, e1, g3, g6, h1, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.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.Since the product was not returned, we were unable to evaluate the device.Therefore, the reported failure cannot be confirmed and cannot determine a root cause.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (health effect clinical code ), h11 corrected field - b5, e3.
Event or Problem Description
It was reported that during insertion of the transray plus 35cc catheter shaft kinked and became unusable.There is no harm or injury.

• 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: 24320849
• Report Number: 2248146-2026-0000683
• Device Sequence Number: 13274198
• Product Code: DSP
• UDI-Device Identifier: 10607567111711
• UDI-Public: (01)10607567111711(17)250703(10)3000487713(11)280703
• 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,Followup,Followup
• Report Date (Section B): 03/06/2026

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: 3000487713
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 03/06/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/05/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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 Sex: Unknown