MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD YAMATO PLUS-R 7.5FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0549-02

Device Problems Restricted Flow rate (1248); Inappropriate Waveform (2536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that after about 5 minutes of intra-aortic balloon (iab) therapy, there was no waveform being generated from the inner lumen.A syringe was connected directly to the inner lumen in an attempt to apsirate blood from the lumen, but was unable to successfully aspirate.The iab was replaced and therapy was provided.There was no reported injury to the patient.

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.Reference complaint (b)(4).Device not returned.

• Brand Name: YAMATO PLUS-R 7.5FR. 35CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17653491
• MDR Text Key: 322320470
• Report Number: 2248146-2023-00537
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0549-02
• Device Lot Number: 3000292872
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EDWARDS PRESSURE TRANSDUCER