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 Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields - b4, d4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h11.A 30cc yamato plus iabc used with a cs300 iabp ruptured on the fourth day after pci support.Alarms sounded repeatedly, and blood was seen in the catheter shaft.The device was replaced with another 30cc balloon from a different manufacturer, and the patient remained unharmed.The balloon had been inserted at another facility via the right femoral artery, where only mild to moderate tortuosity and calcification were present.The rupture occurred while the patient was resting in the icu.Only the catheter and sheath were returned, and details such as the guidewire type, lot number, and serial number are unknown.Physician contact information was not provided since the issue did not occur during the procedure.The product was returned with the membrane completely unfolded and blood on the interior and exterior of the iab and between catheter and sheath.The iab was returned cut at the extracorporeal tubing.The non-maquet sheath was returned covering the catheter tubing.Multiple tiny kinks were observed on the returned sheath near the hub.An underwater leak test of the catheter tubing, inner lumen and extracorporeal tubing was performed and one leak was observed on the membrane 19.8cm from the iab tip and measures 0.005in / 0.013cm long.Conclusion: the reported problems were most likely triggered by three leaks which were found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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.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
Due to characterization limit e1: event site name: (b)(6) hospital.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 record id: (b)(4).
Event or Problem Description
It was reported by the customer that during use the intra-aortic balloon (iab) a balloon rupture and the iab circuit inspection alarm sounded multiple times, and blood was observed inside the catheter shaft.There was no patient harm or injury reported.

• 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: 24032081
• Report Number: 2248146-2026-0000190
• Device Sequence Number: 15738507
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/20/2026
• 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: IABP CS300.
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 56 KG