MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD 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	Leak/Splash (1354)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2020
Type of Reportable Event	Serious Injury
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.(b)(4).Device not returned.
Event or Problem Description
It was reported that after insertion of the intra-aortic balloon(iab), there was a lot of bleeding.The bleeding site was confirmed, blood leaked from the tip of the hub of the sheath.Since it continued to leak continuously, iab's stat guard tip was pushed into the sheath hub to reduce the amount of bleeding.The catheter was removed on (b)(6) 2020.
Additional Manufacturer Narrative
The product was not returned.A video of the reported sheath was provided during its use.The sheath was inserted in the patient, with blood on the device and surrounding insertion area.Further visual examination of the provided video revealed a blood leakage at the sheath hub.The evaluation confirmed the reported problem.However, we were unable to conclusively determine how the leak may have occurred since the device was not returned.A device and 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.Reference complaint #(b)(4).Reference complaint #(b)(4).
Event or Problem Description
It was reported that after insertion of the intra-aortic balloon(iab), there was a lot of bleeding.The bleeding site was confirmed, blood leaked from the tip of the hub of the sheath.Since it continued to leak continuously, iab's stat guard tip was pushed into the sheath hub to reduce the amount of bleeding.The catheter was removed on (b)(6) 2020.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.No blood was observed inside the iab catheter.One kink was found on the catheter tubing approximately 42.4cm from the iab tip.A second kink was found on the catheter tubing and inner lumen approximately 55.4cm from the iab tip.A video was provided.The provided video revealed that blood was leaking from the sheath hub.An underwater leak test of the sheath, sheath seal, balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A catheter tubing kink may cause an opening for blood to pass out of the sheath.However, the reported event cannot be confirmed by the evaluation.A device and 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.Reference complaint # (b)(4).
Event or Problem Description
It was reported that after insertion of the intra-aortic balloon(iab), there was a lot of bleeding.The bleeding site was confirmed, blood leaked from the tip of the hub of the sheath.Since it continued to leak continuously, iab's stat guard tip was pushed into the sheath hub to reduce the amount of bleeding.The catheter was removed on (b)(6) 2020.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g1, g6, h6, h10.Corrected fields: h1, d1, d4.In mfg follow-up #2 the incorrect selection in the "type of reportable event" field (h1) was made.The correct selection of "serious injury" has been selected in the "type of reportable event" field (h1) in this mfg follow-up #3.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. - FAIRFIELD; 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: 10786562
• Report Number: 2248146-2020-00587
• Device Sequence Number: 3732427
• Product Code: DSP
• UDI-Device Identifier: 10607567107585
• UDI-Public: (01)10607567107585(17)221210(10)3000110443(11)191210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: 0684-00-0559-01
• Device Catalogue Number: 0684-00-0559-01
• Device Lot Number: 3000110443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 01/08/2021; 04/03/2025
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/30/2020; 02/02/2021; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown