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

Model Number UNKNOWN

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

Patient Problem Atrial Fibrillation (1729)

Event Date 04/26/2021

Event Type  Injury  

Event Description

Information was obtained from the article "tachycardia-polyuria syndrome after swan-ganz catheterization in liver transplant patient - a case report" by heo et al.2021, and the following complaint was identified: a 41-year-old male undergoing a living-donor liver transplant developed atrial fibrillation during insertion of a swan-ganz catheter.The arrhythmia was treated with esmolol but resolved spontaneously after 9 minutes.The catheter was retracted 15cm and attempted to be fully reinsterted after 20 minutes, but the patient developed atrial fibrillation again.Esmolol and amiodarone were administered without success.The patient required cardioversion to revert to normal sinus rhythm.The surgery was concluded without complication.The device was not available for evaluation.

Manufacturer Narrative

No product was returned for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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.

Manufacturer Narrative

In an article received, a 41-year-old male was scheduled for living-donor liver transplantation.After general anesthesia, atrial fibrillation occurred during swan-ganz catheterization, and polyuria developed 1 h later.Tachycardia-polyuria syndrome is characterized by polyuria occurring because of tachycardia with a heart rate higher than 120 beats/min lasting more than 30 min.Esmolol and amiodarone were administered without success.During the anhepatic phase, the patient's heart rate increased further, and cardioversion was performed.After a normal sinus rhythm was achieved, the patient's urine output returned to normal.Per the ifu for swan ganz cardiac arrhythmias may occur during insertion, withdrawal, and repositioning, but are usually transient and self-limited.Ecg monitoring and immediate availability of antiarrhythmic drugs and defibrillator equipment is recommended.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.Upon further review, 'type of investigation' and 'health effect - impact codes' in h6 were updated.

• Brand Name: SWAN-GANZ CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15311478
• MDR Text Key: 298792932
• Report Number: 2015691-2022-07568
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• 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): Life Threatening
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 87 KG