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	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint id# (b)(4).
Event or Problem Description
It was reported that during use, the intra-aortic balloon (iab) catheter was inserted into the attached sheath.Immediately after inserting the sheath, the balloon catheter became difficult to insert due to tortuosity of the blood vessel.Since there was no alternative another iab catheter was inserted, which made it possible to insert it.
Event or Problem Description
It was reported that during use, the intra-aortic balloon (iab) catheter was inserted into the attached sheath.Immediately after inserting the sheath, the balloon catheter became difficult to insert due to tortuosity of the blood vessel.Since there was no alternative another iab catheter was inserted, which made it possible to insert it.No harm.
Additional Manufacturer Narrative
Updated fields - b4, d4 expiry date, d9 device available for evaluation and date return to manufacturer, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h11 corrected field: b5, d4 udi number, lot number, initially serial number should have kept empty the iab was returned with the membrane folded inside the t-handle.No blood was visible on the catheter.The sheath was not returned for evaluation.The extender tubing was also returned.The iab was removed from the t-handle without difficulty and no damage was observed on the iab catheter.A laboratory insertion test was performed.Since the sheath was not returned a 7.5fr laboratory sheath was used.The technician was able to successfully insert the balloon through the sheath.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The reported event cannot be confirmed by the evaluation.Per ifu the one-way valve must be aspirated to 30cc while leaving the one-way valve in place attached to the extracorporeal tubing leur to ensure vacuum is maintained throughout insertion.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.The device meets all product specifications.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, e1 (event site address, event site city, event site telephone), g3, g6, h2, h11.

• 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: 23572203
• Report Number: 2248146-2025-0000740
• Device Sequence Number: 10155312
• 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: JA
• PMA/510(K) Number: K120868
• 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): 01/28/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 01/26/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/19/2026; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 30CC ZEON IAB CATHETER.
• Patient Sex: Unknown