MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 777F8

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that during use of this swan-ganz catheter there was medication loss or catheter occlusion occurred.On (b)(6) 2024, medications (catecholamine) were injected from the white port of the swan-ganz cco catheter at a flow rate of about 50 cc per hour, but the patients blood pressure was unstable.The blood pressure became stable when the medications were injected from the side tube of the sheath introducer at the same flow rate.The next day on (b)(6) 2024, the customer tried flushing from the white port of the suspect catheter using a syringe, but flushing was not possible as the syringe was too stiff to push.Flushing became possible after suctioning with the syringe forcibly.This led to a suspicion of occlusion of the white port of the catheter at the time of procedure on march 11th.However, since no alarm was confirmed in the syringe pump at this time, it was assumed that the syringe pump was operating at a predetermined pressure.Therefore, the problem seemed to be the medications were pushed out with the syringe, but it was not injected into the patients body properly.In addition, it was reported that during use of this catheter on march 11th, water droplets were found in the bellows like section connected to the introducer.However, there were no water leakage confirmed when the catheter flush test was performed.It was possible that the leakage occurred between the introducer and the catheter.The introducer which was used with this catheter will be investigated at the manufacturer of this introducer after its removal.The catheter was replaced with a new one and there were no issues with the new catheter.Patient demographics were requested but unavailable.It is unknown what kind of surgery the catheter was used for or whether there were any patient complications.

Manufacturer Narrative

Our product evaluation lab received one 777f8 catheter with attached monoject 1.5 cc limited volume syringe, 2 three-way stopcocks, and nipro 25 ml syringe.The reported issue of leakage or occlusion was unable to be confirmed during the evaluation.There was no visible damage or abnormality observed from the catheter body, balloon, inside connectors, or the returned syringe.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric, and remained inflation for five minutes without leakage.A device history record review was unable to be completed as the lot number is unknown.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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 a part of the monthly review.

• Brand Name: SWAN-GANZ CCOMBO THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• 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
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19029205
• MDR Text Key: 339916848
• Report Number: 2015691-2024-02499
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/02/2024
• 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