MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP THERMODILUTION CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number T173F6

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This double balloon technique is not recommended or stated in the ifu.There were alleged patient complications, but additional information is unknown.It was confirmed that the customer considered the event as an off-label use, and it was not related to the device malfunction.The ifu indicates the following warning related the balloon inflation: warning: pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, do not inflate above the recommended volume.The ifu also provides instructions to verify the catheter / balloon integrity before insertion: catheter preparation: flush catheter lumens with a sterile solution to ensure patency and to remove air.Check balloon integrity by inflating it to the recommended volume.Check for major asymmetry and for leaks by submerging in sterile saline or water.Deflate balloon before insertion.This is considered use-error and will be addressed to the customer in a letter, describing proper techniques for insertion as well contraindications that are stated in the ifu.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that during use with this catheter, it was unable to float to the pulmonary artery (pa), therefore the customer inflated the balloon twice as big as the recommended volume, which is this facility calls the double balloon technique.Patient complications were reported due to this procedure; however, the details are unknown.It was confirmed that the customer considered the event as an off-label use, and the complications were not related to a device malfunction.Despite follow up attempts for further information, the details of patient complications could not be obtained.Patient demographic information was requested but unavailable.The device was discarded by the hospital.

• Brand Name: SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP THERMODILUTION CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12926746
• MDR Text Key: 283175935
• Report Number: 2015691-2021-06662
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K915726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: T173F6
• Device Catalogue Number: T173F6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other