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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the cardiac emergency and after surgery the yamato plus-r 30cc intra-aortic balloon (iab) with accessories and retraction kit was removed to stabilize the patient's condition, but blood was drawn into the balloon.There was no effect on the patient.
Additional Manufacturer Narrative
Due to characters limitations, e1 (initial reporter) 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.
Additional Manufacturer Narrative
Updated fields: b4; g3; g6; h2; h3; h4; h6 problem code, type of investigation, investigation findings, investigation conclusion; h11.Corrected fields: b3; d4 udi number, lot number; d7a; d9 device available for evaluation, return to manufacture date; e1 telephone number.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.A non-maquet three-way stopcock was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and a leak was detected on the membrane approximately 1.8cm from the rear seal measuring 0.013cm length.The reported failure was confirmed by the evaluation.The reported problems were most likely triggered by a leak which was found on the membrane by the rear seal.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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.The reported failure was confirmed by the evaluation.The reported problems were most likely triggered by a leak which was found on the membrane by the rear seal.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.
Additional Manufacturer Narrative
Updated fields: b4; g3; g6; h11 the product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between catheter and sheath.Two kinks observed on the catheter tubing 71.9cm and 63cm from the iab tip.The non-maquet sheath was returned covering the catheter tubing.A non-maquet three-way stopcock was also returned.- an underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing and a leak was detected on the membrane approximately 1.8cm from the rear seal measuring 0.013cm length.The reported failure was confirmed by the evaluation.The reported problems were most likely triggered by a leak which was found on the membrane by the rear seal.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.A lot of 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.The reported failure was confirmed by the evaluation.The reported problems were most likely triggered by a leak which was found on the membrane by the rear seal.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.

• 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21685681
• Report Number: 2248146-2025-0000166
• Device Sequence Number: 9308202
• 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
• 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): 06/03/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 05/30/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown