MAUDE Adverse Event Report: ICU MEDICAL, INC. PA CATHETER; CATHETER, FLOW DIRECTED

Lot Number 85-785-JW

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2019

Event Type  malfunction  

Event Description

Before inserting a pulmonary artery catheter the doctor checked the catheter and balloon.The balloon would not inflate.Catheter removed from service.

• Brand Name: PA CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 8757860
• MDR Text Key: 149948382
• Report Number: 8757860
• Device Sequence Number: 1
• Product Code: DYG
• 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: 06/10/2019

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 Lot Number: 85-785-JW
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1