MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CATHETERS; CATHETER, FLOW DIRECTED

Model Number SWAN GANZ MODEL UNKNOWN

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

Patient Problems Cardiac Tamponade (2226); Insufficient Information (4580)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

It is unknown if this device is available for return.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.A supplemental report will be forthcoming with the investigation results when completed.Neither the model nor the lot numbers were supplied for this device; therefore, the related manufacturing records were unable to be reviewed.Based on the swan ganz catheter instructions for use (ifu), the thermodilution catheter series is for use in patients who require hemodynamic monitoring.They are intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with a compatible cardiac output computer to continuously measure cardiac output.Edwards has no data to support the use of the swan ganz catheter with the ethanol ablation of the vein of marshall procedure.This adverse event appears to be caused by device handling and/or manipulation.

Event Description

As reported, prior to an atrial fibrillation ablation procedure in a patient, with this swan ganz catheter, a cardiac tamponade was noted when the physician was performing a vein of marshall ethanol infusion.Therefore, the procedure was abandoned.It was specified that the perforation occurred when the physician pushed the balloon in the distal part of the coronary sinus and the patient became hypotensive and their capnia rose.Heparin was used during the procedure and no ablations were performed as of yet.A thoracotomy was performed in order to stabilize the patient.The physician indicated that the swan-ganz balloon could have been the cause of the cardiac tamponade.The patient was then sent to intensive care and was intubated and ventilated.Patient demographics were requested; however, unable to be obtained.Despite three attempts, no further event information was available and no response was provided regarding the device availability for examination.

Manufacturer Narrative

No further information regarding the reported event or the device availability could be obtained from the customer after three attempts.The reported event could not be confirmed since the complaint affected unit was not returned for evaluation.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.H3 other text : the device was not available.

• Brand Name: SWAN-GANZ CATHETERS
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• MDR Report Key: 12126929
• MDR Text Key: 260222628
• Report Number: 2015691-2021-03933
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ MODEL UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention