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	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The failure mode of difficult or unable to insert intra-aortic balloon (iab) through sheath occurs when the intra-aortic balloon (iab) catheter cannot be smoothly advanced through the supplied introducer sheath.The issue may involve increased resistance, halted advancement, or complete blockage.As a result, proper catheter placement may be compromised, therapy may be delayed, and device replacement may be required.Potential causes are as follows mechanical or structural issues can prevent the catheter from passing through the sheath.Broken inner lumen disrupts internal pathway for catheter passage.Inner lumen kink bending or collapse of lumen restricting movement.Catheter kink deformation of the catheter body causing resistance.Unfolded iab membrane balloon membrane not tightly wrapped increasing bulk and obstructing insertion.
Event or Problem Description
It was reported that during use, after inserting the terumo 8f sheath, we attempted to insert the iab catheter, but the balloon wrapping came undone, preventing it from passing through the sheath.We had performed negative pressure work on the balloon using a one-way valve, so the balloon wrapping should have been done properly.When we inserted another trp4046 catheter using the same procedure, the balloon was securely wrapped and passed through the sheath without any problems.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: a4, h6 (type of investigation).

• 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: 24838831
• Report Number: 2248146-2026-0000869
• Device Sequence Number: 6012021
• Product Code: DSP
• UDI-Device Identifier: 10607567111728
• UDI-Public: (01)10607567111728(17)280402(10)3000464531(11)250402
• 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): 05/06/2026

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: 0684-00-0608
• Device Catalogue Number: 0684-00-0608
• Device Lot Number: 3000464531
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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: TERUMO 8F SHEATH
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 65 KG