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	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 intra-aortic balloon therapy, the balloon did not expand.
Event or Problem Description
It was reported that during the intra-aortic balloon therapy, the balloon did not expand.There was no injury and harm reported.
Additional Manufacturer Narrative
Updated filed: b4, d9, e2, e3, g3, g6, h2, h3, h6 (health effect ¿ clinical code, type of investigation, investigation findings, component codes, health effect ¿ impact codes and investigation conclusions) and h11.Corrected fields: d8.The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between catheter and sheath.The non- maquet sheath was returned covering the catheter tubing and a small portion of the rear seal.A bend was observed on the returned sheath exterior.One kink was observed on the catheter tubing approximately 71.3cm from the iab tip.The extender tubing, pressure tubing, one-way valve and three-way stopcock were also returned.The inner-lumen was found to be occluded.The occlusion was unable to be cleared.Multiple bends were observed on the inner-lumen within the membrane part of the iab.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing, extender tubing and pressure tubing was performed and a leak was detected on the membrane approximately 2.8cm from the rear seal measuring 0.139cm length.One-way valve vacuum test was preformed, and it was able to hold vacuum the reported problems were most likely triggered by a leak which was found on the membrane by the rear seal.The leak size suggests that a sharp object may have caused it, no marks were found around the leak.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.
Event or Problem Description
Na.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between catheter and sheath.The maquet sheath was returned covering the catheter tubing and a small portion of the rear seal.A bend was observed on the returned sheath exterior.One kink was observed on the catheter tubing approximatley 71.3cm from the iab tip.The extender tubing, pressure tubing, one-way valve and three-way stopcock were also returned.The inner-lumen was found to be occluded.The occlusion was unable to be cleared.Multiple bends were observed on the inner-lumen within the membrane part of the iab.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing, extender tubing and pressure tubing was performed and a leak was detected on the membrane approximately 2.8cm from the rear seal measuring 0.139cm length.One-way valve vacuum test was preformed, and it was able to hold vacuum.The reported problems were most likely triggered by a leak which was found on the membrane by the rear seal.The leak size suggests that a sharp object may have caused it, no marks were found around the leak.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.

• 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: 22130429
• Report Number: 2248146-2025-0000293
• Device Sequence Number: 12864098
• Product Code: DSP
• UDI-Device Identifier: 10607567107585
• UDI-Public: (01)10607567107585(17)260313(10)3000303715(11)230314
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2025

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: 03/13/2026
• Device Model Number: 0684-00-0559-01
• Device Catalogue Number: 0684-00-0559-01
• Device Lot Number: 3000303715
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 09/11/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/11/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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 Sex: Unknown