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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: teacher additional reporter: (b)(6) complete event site name: (b)(6) center 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) h3 other text : device not returned.
Event or Problem Description
It was reported that the intra-aortic balloon (iab) had an abnormal position of the x-ray marker.It was noted that the patient had been transferred in from another facility.After checking the fluoroscopic image, it appeared that the marker on the base side of the iab had moved toward the tip of the iab.The iab was then removed.Upon inspection, the physician noted that it seemed as though there was an opaque marker inside the iab.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.The pressure tubing was also returned.Visual examination confirmed that the rear tantalum marker was found misplaced next to the front marker.The root cause of the reported failure ¿iab - iab migrated & difficult/unable to view marker¿ was found to be rear tantalum migration that happened after the tantalum became unattached from the inner lumen.The tantalum migration is unlikely to have occurred within the manufacturing facility.The dhr was reviewed, as well as the training record of the operator, and the setup sheet of the dispenser; no issues were found.The iab was deemed acceptable prior to leaving the manufacturing facility.Each iab is tested multiple times to check the correct assembly and location of the rear tantalum marker.Furthermore, the manufacturing process was reviewed, and no issues were identified.The root cause of the tantalum migration cannot be determined, as it occurred after shipment of the device and was out of getinge¿s control.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.
Additional Manufacturer Narrative
Firm has provided updated device identification information in alignment with gudid.Complaint record id # (b)(4).
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.The pressure tubing was also returned.Visual examination confirmed that the rear tantalum marker was found misplaced next to the front marker.The root cause of the reported failure ¿iab - iab migrated and difficult/unable to view marker¿ was found to be rear tantalum migration that happened after the tantalum became unattached from the inner lumen.The tantalum migration is unlikely to have occurred within the manufacturing facility.The dhr was reviewed, as well as the training record of the operator, and the setup sheet of the dispenser; no issues were found.The iab was deemed acceptable prior to leaving the manufacturing facility.Each iab is tested multiple times to check the correct assembly and location of the rear tantalum marker.Furthermore, the manufacturing process was reviewed, and no issues were identified.The root cause of the tantalum migration cannot be determined, as it occurred after shipment of the device and was out of getinge¿s control.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).Reference complaint (b)(4).

• 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.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 17852176
• Report Number: 2248146-2023-00596
• Device Sequence Number: 3353298
• 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
• Serviced by Third Party (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): 03/06/2025

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: 11/20/2025
• Device Model Number: 0684-00-0559-01
• Device Catalogue Number: 0684-00-0559-01
• Device Lot Number: 3000281458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 02/28/2024; 09/16/2024; 02/18/2025
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 02/28/2024; 09/16/2024; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown