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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, at 1:30, during intra-aortic balloon (iab) therapy on a patient with acute myocardial infarction (ami), the iab membrane would not inflate while being used on a cs300 intra-aortic balloon pump (iabp).The hospital staff attempted to restart the procedure several time, but the problem persisted.Since the issue could not be resolved, the inserted iab was removed and percutaneous coronary intervention (pci) was completed without iabp support.Fluoroscopy showed that the balloon was not coming out of the sheath.There was no reported injury to the patient.
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Event site postal code: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint # h3 other text : device not returned.
Additional Manufacturer Narrative
Udi related data quality updates only: providing updated device identification information in alignment with gudid.Complaint record id # (b)(4).
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
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 18048456
• Report Number: 2248146-2023-00651
• Device Sequence Number: 8254720
• Product Code: DSP
• UDI-Device Identifier: 10607567107585
• UDI-Public: (01)10607567107585(17)251120(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
• Report Date (Section B): 09/11/2024

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: 11/20/2025
• Device Model Number: 0684-00-0559-01
• Device Catalogue Number: 0684-00-0559-01
• Device Lot Number: 3000281458
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 09/11/2024
• 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: CS300.
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 45 KG