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

Model Number 744F75

Device Problems Incorrect Measurement (1383); Inaccurate Information (4051)

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

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

One swan-ganz catheter was received by our product evaluation laboratory for a full examination.The report of cardiac output (co) issue could not be confirmed.As received, no fault messages showed up on the lab vigilance ii monitor when the catheter was connected.The thermistor was found to read 37.2 c when submerged into a 37.0 c water bath.The catheter ran cco in 37.0 c water bath on vigilance ii monitor for five minutes without error.Thermistor and thermal filament circuit were continuous, there were no open or intermittent conditions.No visible inconsistence was observed on eeprom data.Resistance value of thermal filament circuit was measured 38.60 ohms.Both thermistor and thermal filament connectors were opened and found no visible inconsistencies.No visible damage or inconsistency was observed from catheter body, balloon or returned syringe.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than five minutes without leakage.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.Based on further engineering investigation, the units go through an electrical inspection as part of the manufacturing process.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, after correct calibration and during use of this swan-ganz catheter in a patient under pulmonary hypertension (medwatch #13449), the continuous cardiac output (cco) values were lower (2l/min) than expected (around 3l/min).The user tried to get measurements again but the values were still low.The swan-ganz catheter was changed but the cco provided was higher than expected (7l/min) (medwatch #13450).Using a third swan-ganz the issue was solved.There was no allegation of patient injury.

Manufacturer Narrative

As per further review, the device code in h6 has been updated to reflect most accurate nature of this issue.Additionally, date of event has been rectified.

• 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: 13798999
• MDR Text Key: 287710214
• Report Number: 2015691-2022-04472
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 744F75
• Device Catalogue Number: 744F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 87 KG