MAUDE Adverse Event Report: Datascope Corp. YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0559-01
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Other
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b1, b4, d10, d9, g3, g4 (pma 510k), g6, g7, h2, h6 (type of investigation, investigation findings, component codes, and investigation conclusions), h11 corrected fields: d8 (revert this field to blank, as it was inadvertently submitted initially) since the product was not returned, we were unable to evaluate the device.Potential causes of the reported issue could be an obstruction within the inner lumen or restriction (kink) within the iab catheter, guidewire and/or inner lumen that prevented passage of the guide wire.The fact that two different 0.025-inch guidewires became stuck within the same catheter, while an alternative manufacturer's catheter functioned normally under the same procedural conditions, suggests the issue was likely specific to the affected device.Based on the available information and without the return of the device we are unable to confirm the exact cause of the reported failure mode of not being able to to insert the guidewire though the iab.No decon or visual inspection performed since product was not returned and could not be evaluated.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses 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.Based on the rationality provided above, no escalation to the capa process is required.

• Brand Name: YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT
• 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: 50294387
• Report Number: 2248146-2026-0001414
• Device Sequence Number: 15876598
• Product Code: DSP
• UDI-Device Identifier: 10607567107585
• UDI-Public: (01)10607567107585(17)260807(10)3000327935(11)230807
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 08/07/2026
• Device Model Number: 0684-00-0559-01
• Device Catalogue Number: 0684-00-0559-01
• Device Lot Number: 3000327935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 88 LB