MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR SWAN-GANZ THERMODILUTION CATHETER; PULMONARY ARTERY CATHETER, THERMAL DILUTION

Model Number 831F75P

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.One swan-ganz catheter was received by our product evaluation laboratory for a full examination.As received, balloon was found to be completely detached and not returned.Residual adhesive and residual latex were not observed at the bonds.All through lumens were patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body.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

As reported, before use in patient, the balloon of this swan-ganz catheter deflated automatically after inflation.There was no allegation of patient injury.The device was received for evaluation.As received, balloon was found to be completely detached and not returned.Patient demographic information not available.

Manufacturer Narrative

Updated: h6 (component code, investigation findings, investigation conclusion).Added: h6 (type of investigation).Further investigation was performed by engineers in the manufacturing site and this condition is potentially related to manufacturing.The product evaluation reported a missing balloon.However, there are current risk mitigations that include design and manufacturing controls, ifu warnings and cautions, and physician training of proper catheter preparation.Nevertheless, a personnel acknowledgment was provided to the manufacturing personnel to inform about this nonconformance.This was considered an isolated case.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• Type of Device: PULMONARY ARTERY CATHETER, THERMAL DILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18844420
• MDR Text Key: 337008991
• Report Number: 2015691-2024-01621
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 831F75P
• Device Lot Number: 64767809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2023
• 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