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

Catalog Number 0684-00-0604

Device Problems Restricted Flow rate (1248); Optical Problem (3001)

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: (b)(6).Event site name: (b)(6) hospital 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).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the cs300 intra-aortic balloon pump (iabp) generated a "sensor calibration error/optical sensor failure" alarm.An attempt was made to secure arterial pressure by connecting a blood pressure transducer to the inner lumen, but the arterial pressure could not be measured due to an inner lumen occlusion.Heparock may have been insufficient because the inner lumen was able to be used until the iab was placed.Clinically, heparock is used as an electrocardiogram trigger, and the arterial pressure was handled by the radial pressure.The location of use was a cardiac catheterization laboratory, and the tortuosity of the blood vessel was slight.There was no scarring at the right femoral insertion site.The sheath was an 8fr 10cm made by another company.The calcification of the artery was mild, and the guidewire used was the included 0.025 guidewire.The patient's vitals were stable, blood pressure was normal, and the patient was able to get out of bed early.Therapy was successfully completed after eight hours.There was no patient harm or adverse event reported.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 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: 18056866
• MDR Text Key: 327182332
• Report Number: 2248146-2023-00653
• 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: Physician
• Type of Report: Initial
• Report Date: 11/02/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2024
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000140639
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CS3008FR 10CM SHEATH MADE BY ANOTHER COMPANY.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 57 KG