MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, OXIMETER, FIBEROPTIC

Model Number 139F75

Device Problem Poor Quality Image (1408)

Patient Problems Dyspnea (1816); Pneumonia (2011); Respiratory Distress (2045)

Event Date 02/05/2017

Event Type  malfunction  

Event Description

Male patient presented to the emergency room then admitted to hospital with history of copd and is post 3 days w/dyspnea, cough, shortness of breaths.Patient was intubated after bipap.Pneumonias in both lower lobes.On day 6 of icu a thermodilution catheter placed for monitoring in patient.Pulmonary artery waveform kept dampening and not showing correct waveform for being in pulmonary artery.Doctor manipulated multiple times to correct waveform which would show a pulmonary artery waveform but the waveform would dissipate despite the catheter not being manipulated and showing good position.New swan placed showing good waveform with no issues.Device saved for team leader/manager then on to risk mgmt.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 6375927
• MDR Text Key: 68991917
• Report Number: 6375927
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2017,02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/23/2018
• Device Model Number: 139F75
• Device Catalogue Number: 139F75
• Device Lot Number: 60561896
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 90