MAUDE Adverse Event Report: DATASCOPE CORP. MAQUET MEGA IAB (INTRA-AORTIC BALLOON) CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0497

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

Event Type  malfunction  

Event Description

50 cc balloon pump inserted into patient.One minute after starting it said, "leak in circuit" and stopped itself.It had to be taken out of the patient and inspected.No malfunctions found.Another balloon pump inserted.

• Brand Name: MAQUET MEGA IAB (INTRA-AORTIC BALLOON) CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11669450
• MDR Text Key: 245525108
• Report Number: 11669450
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/25/2021,03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000125183
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 88