MAUDE Adverse Event Report: DATASCOPE CORP. IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Device Problem Gas/Air Leak (2946)

Patient Problem Thrombus (2101)

Event Date 10/21/2019

Event Type  malfunction  

Event Description

Pt.Had a left axillary intra-aortic balloon pump (iabp) placed as a bridge to heart transplant.Approximately 2 weeks later, the patient experienced air loss alarms in the iabp.The console was changed, and augmentation adjusted without resolution of the intermittent alarms.Pt.Was taken to the or for suspected helium leak.A new balloon pump was successfully placed.Post op note stated findings: "stable fibrin/thrombus found partially occluding the gortex graft.".

• Brand Name: IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9659331
• MDR Text Key: 177378531
• Report Number: 9659331
• 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: 10/24/2019,10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA