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

Model Number 744F75

Device Problem Inaccurate Information (4051)

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

As reported, after correct calibration and during use of this swan-ganz catheter in a patient under pulmonary hypertension (medwatch #(b)(4)), 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 #(b)(4)).Using a third swan-ganz the issue was solved.There was no allegation of patient injury.

Manufacturer Narrative

One swan-ganz catheter was received by our product evaluation laboratory for a full examination.The report of cardiac output (co) issue was confirmed.As received, the catheter was connected to the vigilance ii monitor, and "check thermal filament connection" error message was displayed.Continuity testing confirmed a full open condition in the thermal filament circuit.Thermal filament connector was opened.Continuity test confirmed an open condition at one of the solder joints between the leadwire and circuit board inside the thermal filament connector.No visible inconsistency was observed on eeprom data.The thermistor was found to read 37.3 c when submerged into a 37.0 c water bath.The thermistor circuit was continuous and there were no open or intermittent conditions observed.Catheter failed in-vitro calibration with the lab cal-cup.Visual examination found the surface of the fibers at the tip was rough.When the catheter tip was exposed to light, the transmitted light on one of the fibers appeared off-center.Optic connector was opened.No light leakage was observed from the optical fibers in the optic connector.No visible damage or abnormalities was observed from the catheter body or balloon.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric, and remained inflated for five min without leakage.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.An engineering investigation has been initiated to consider any potential factors that may have contributed to this 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 part of this monthly review.

Manufacturer Narrative

Further investigation was performed by the engineers at the manufacturing site.The root causes for the open condition at leadwire and optical transmission failure could potentially be related to the manufacturing process, according to their respective capa investigation.Corrective actions are being implemented in order to eliminate the cause of the non-conformity and prevent recurrence of these type of non-conformances.On the other hand, a product risk assessment was generated regarding the open condition at leadwire.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.

• 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: 13798935
• MDR Text Key: 296997564
• Report Number: 2015691-2022-04471
• 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: 05/12/2022

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 Expiration Date: 09/28/2022
• Device Model Number: 744F75
• Device Catalogue Number: 744F75
• Device Lot Number: 63418008
• 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: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2020
• 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