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

Model Number 744F75

Device Problem Incorrect Measurement (1383)

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

Event Date 06/09/2022

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 a supplemental report will be sent with the investigation results.

Event Description

As reported, when placing this swan-ganz catheter, the balloon inflation affected the inner diameter of the lumen, and therefore pressure values were inaccurate.There were neither alarm nor error message displayed.The value was recognized as inaccurate and therefore there was no additional treatment.The user suspected that there was an occlusion on the tip of the catheter.Patient demographics were requested but unable to be obtained.There was no allegation of patient injury.Follow up has started for device return.

Manufacturer Narrative

The swan-ganz catheter was received at our product evaluation laboratory for a full evaluation.Evaluation results revealed the reported event of inaccurate values could not be confirmed.The balloon inflated but failed to maintain its inflation due to an interlumen leakage in the catheter body around catheter tip between balloon inflation lumen and distal lumen.Proximal injectate lumen and proximal infusion lumen were patent without any leakage or occlusion.No visible damage was observed from the catheter body and balloon.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.The following additional information was provided.The issue occurred when this swan ganz catheter was placed in the pulmonary artery; therefore the pulmonary artery values were inaccurately displayed.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

The device has been re-evaluated.Results update: the reported events of "inaccurate values" and "distal lumen occluded" could not be confirmed since no defect was found on the returned device.No fault messages showed up on the laboratory vigilance ii monitor when the catheter was connected.The thermistor was found to read 36.7 c when submerged into a 37.0 c water bath.Thermistor temperature reading accuracy is +/- 0.3 c per vigilance ii manual.The catheter ran continuous cardiac output (cco) in the 37.0 c water bath on vigilance ii monitor for 5 minutes without error.The thermistor and thermal filament circuit were continuous, there were no open or intermittent conditions.No visible inconsistencies were observed on eeprom data.Resistance value of thermal filament circuit was measured at 36.07 ohms which was within specification.Catheter also passed in-vitro calibration with laboratory cal-cup.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No visible damage or inconsistency was observed from catheter body.Further analysis was performed.This catheter model has a distal and proximal injectate through lumens.All through lumens were patent without any leakage or occlusion.All through lumens from the catheter passed the pressure test with laboratory dpt.Further investigation was performed by the engineers at the manufacturing site.The devices go through leak and flow test, in addition to balloon inflation and visual inspection during 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.

• 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: 14915442
• MDR Text Key: 301941432
• Report Number: 2015691-2022-06616
• 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,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: 744F75
• Device Catalogue Number: 744F75
• Device Lot Number: 64050281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2021
• 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