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	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1 event site city is (b)(6).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 that during the insertion of an iabc (ymt30r-01) for post-pci support in a patient with ami, the iabc's placement slipped into the abdomen during fluoroscopic confirmation in the catheterization laboratory.Despite repeated attempts to correct the position under the gw, the condition did not improve, so the risk was assessed and the iabc was removed.Because the same size (30cc) catheter was unavailable, we considered inserting a 35cc catheter (trp3546), but since blood pressure was maintained, we discontinued iab treatment and focused solely on medication control.This incident did not pose any health risks to the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2,h11.Corrected field: d4 lot number.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: e1(event site email) - revert it back to blank, id is not disclosed initially it was incorrectly submitted, e1(event site telephone), e2.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.

• 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: 23025302
• Report Number: 2248146-2025-0000546
• Device Sequence Number: 9181840
• 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,Followup
• Report Date (Section B): 10/03/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/03/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 09/26/2025; 10/03/2025
• 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: 48 KG