MAUDE Adverse Event Report: DATASCOPE CORP. YAMATO PLUS-R 30CC IAB WITH ACCESSORIES AND RETRACTION KIT (APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0559-02
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (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 intra-aortic balloon (iab) therapy, the customer noticed abnormal marker position.The distal marker and proximal marker were too close during fluoroscopic confirmation.This issue had no effect on the pressure/ waveform readings or pumping.It was assumed that the proximal side marker had come off and shifted to the center of the iab shaft (raised to the top).In consideration of the risk of iab rupture, it was removed.A new iab was inserted to continue therapy.There was no patient harm or adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Photos of x-rays were provided by the facility.Based on the limited information available, we are unable to confirm if the marker is misaligned or if there was an issue during insertion or other use of the device.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.Reference complaint (b)(4).
Additional Manufacturer Narrative
Providing updated device identification information in alignment with gudid update to investigation: no decon or visual inspection performed since product was not returned and could not be evaluated.The video and photos from the facility shows an x-ray of the iab inside of the patient, which confirms the reported failure.We are unable to determine when this may have occurred.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint (b)(4).
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:b4, g1, g3, g6, g7, h2, h11.No decon or visual inspection performed since product was not returned and could not be evaluated.The video and photos from the facility shows an x-ray of the iab inside of the patient, which confirms the reported failure.We are unable to determine when this may have occurred.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).

• Brand Name: YAMATO PLUS-R 30CC IAB WITH ACCESSORIES AND RETRACTION KIT (APA)
• 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 18607324
• Report Number: 2248146-2024-00058
• Device Sequence Number: 11449813
• Product Code: DSP
• UDI-Device Identifier: 10607567107592
• UDI-Public: (01)10607567107592(17)251121(10)3000281458(11)221121
• 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,Followup
• Report Date (Section B): 03/03/2025

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: 11/21/2025
• Device Model Number: 0684-00-0559-02
• Device Catalogue Number: 0684-00-0559-02
• Device Lot Number: 3000281458
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 10/17/2024; 02/14/2025
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/19/2024; 10/21/2024; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2022
• 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 8FR. SHEATH.
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 63 KG