MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ PACERPORT CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 931F75

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2019

Event Type  malfunction  

Event Description

The pa / distal port of the swan-ganz catheter port spontaneously disconnected from the main plastic (triangle) plastic piece where all lumens meet.Blood was flowing from the catheter.Rn was in the pt's room at the time and was immediately recognized and intervened upon.A new swan-ganz catheter was inserted at a different site.Fda safety report id# (b)(4).

• Brand Name: SWAN-GANZ PACERPORT CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 8869227
• MDR Text Key: 153856826
• Report Number: MW5088856
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/05/2019

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 Model Number: 931F75
• Device Catalogue Number: 931F75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other