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

Model Number 774F75

Device Problem Material Rupture (1546)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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 product is expected to be returned for analysis; however, it has not yet been received.

Event Description

As reported, this swan-ganz catheter was placed in patient.The balloon was tested before insertion, and it was functional.However, upon returning to intensive care, the nurse noticed that the balloon syringe seemed to indicate an inflated balloon.The nurse transmitted to the doctor who attempted to repeat pulmonary artery occlusion pressure (paop) measurement.However, occlusion was not achievable.The swan ganz probe was then removed, and it was noticed that the balloon was pierced.Consequently, the patient had to return to the catheterization room for a swan-ganz catheter replacement.A new introducer was used on a new site.There was no allegation of patient injury.Patient demographics were asked.The device was available for evaluation.

Manufacturer Narrative

One swan ganz catheter was received for evaluation.The report of balloon issue was confirmed.Balloon did not inflate due to leakage from a tear at distal balloon bonding site.The tear size was approximately 2 mm in length.The edges of tear appeared to match up.All through lumens were patent without any leakage or occlusion.No visible damage or abnormality was observed from catheter body and syringe.

• 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 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: 18895546
• MDR Text Key: 337644500
• Report Number: 2015691-2024-01981
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• 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