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

Model Number 131F7J

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/29/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced a potential latex allergic reaction from a 131f7j swan-ganz catheter on the first day of use.The device is not planned to be returned for product evaluation.The lot number is unknown.

Manufacturer Narrative

The device was discarded at the facility.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No corrective actions will be taken at this time.The instructions for use of swan-ganz thermodilution catheter states caution that this product contains natural rubber latex which may cause allergic reactions.In addition, allergic reactions to latex have been reported.Physicians should identify latex sensitive patients and be prepared to treat allergic reactions promptly.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results indicate root cause is likely to be related to use error.The ifu has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions and, 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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

A supplemental mdr is being submitted due to the change in reportability from the updated information from the sales rep and the removal of the h6 codes.In this event, it was originally reported that there was a potential latex allergic reaction to a edwards swan ganz catheter, however, it was confirmed that there was no allegation of latex allergic reaction to a edwards product or any allegation of product malfunction.This is no longer a reportable event.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

Additional and correct information from the sales rep was provided.The initial report was confirmed to be incorrect and no latex allergic reaction from ew product occurred.It turned out to be an inquiry from the facility regarding whether edwards manufactures latex-free swan ganz and vascular catheters.Incorrect information was received since multiple people from the facility, supply processing and distribution (spd) center at the hospital and distributor were involved in the communication.

• Brand Name: SWAN-GANZ THERMODILUTION 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 18744052
• MDR Text Key: 335813389
• Report Number: 2015691-2024-01177
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 131F7J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• 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: Unknown
• Patient Sequence Number: 1