MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION; CATHETER, FLOW DIRECTED

Model Number D97130F5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the device it is not possible to assess any manufacturing issues with the device.The lot number was not provided thus a device history record was not reviewed.The instructions for use , under complications perforation of the right ventricle states as follows, cases of myocardial perforation associated with the use of temporary transvenous pacing catheters have been reported.Careful repositioning and withdrawal of the catheter under ecg and fluoroscopic control is recommended.The instructions for use has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions or conditions for the successful use of the device.Complaint histories for all reported events are reviewed through trending on a monthly basis and continue to be monitored for any unfavorable trends and documented as part of this monthly review.No corrective or preventative actions are required at this time.

Event Description

It was reported that the tip of a pacing catheter perforated the right ventricle when the catheter was inserted and led to cardiac tamponade.Pericardial drainage was performed.The customer thought that the adverse events were related to the catheter, because the catheter tip felt stiffer than usual.The device was discarded at the hospital.Patient demographic information, outcome, and status was requested but is unknown, further information could not be obtained as reporter declined to be interviewed.

• Brand Name: SWAN GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18886210
• MDR Text Key: 337444107
• Report Number: 2015691-2024-01951
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K822723
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: D97130F5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other