MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ UNKNOWN; ELECTRODE, PACEMAKER, TEMPORARY

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/04/2024

Event Type  malfunction  

Event Description

It was reported that the customer had a paceport swan-ganz catheter in a patient for four days.The nurse shot thermodilution co and noticed there was an unexpected change in hemodynamics.The patients co went from 6-7 to 14-17l per min with ci > 4.Svr was in the 500s prior to this change.There was concern for systemic inflammatory response syndrome.The customer also noted that there was backflow into pacer port which is where the patients vasopressors were infusing.This occurred more than once with this patient.Decision was made to pull swan.Trouble shooting included reassessing the location of the swan via chest x-ray and assessment for blood return of port.The customer confirmed there was no patient injury.

Manufacturer Narrative

The evaluation is anticipated.However, the complaint cannot be confirmed without the completion of an evaluation.A supplemental report will be forthcoming when the investigation is completed.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.H3 other text : customer confirmed device will not be returned but an engineering evaluation will be performed.

Manufacturer Narrative

Our product evaluation lab received one model 931f75 swan ganz catheter.The customer report of leakage issue was confirmed.Proximal injectate lumen was occluded with blood at the lumen port and there was an interlumen leakage between proximal injectate lumen and rv pacing lumen.After blood occlusion was cleared, interlumen leakage was found to be in the backform.The thermistor was found to read 37.0 c when submerged into a 37.0 c water bath.Thermistor temperature reading accuracy is +/- 0.3 c per hemosphere manual.Thermistor circuit was continuous, there were no open or intermittent conditions.The balloon inflated clear, concentric and remained inflated for more than 5 min without leakage.Distal lumen was patent without any leakage or occlusion.No visible damage was observed from the catheter body, balloon and returned syringe.Report of co issue was unable to be confirmed.However, per ifu to determine cardiac output by thermodilution, a known amount of sterile solution of known temperature is injected into the right atrium or vena cava, and the resultant change in blood temperature is measured in the pulmonary artery by the catheter thermistor.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.A potential root cause for interlumen leakage is associated to the manufacturing process.As part of the manufacturing process, 100% of the units go through a leak test inspection process.In addition, to the leak test inspection, as part of the manufacturing process a balloon inflation inspection is performed to a 100% of the manufactured units.Based on the available information the specific cause of the interlumen leakage could not be confirmed by the investigation, therefore, a root cause could not be determined.The lot number was not provided thus a device history record was not reviewed.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 UNKNOWN
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18754532
• MDR Text Key: 336089927
• Report Number: 2015691-2024-01203
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 04/05/2024
• 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