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

Model Number 774F75

Device Problem Incorrect Measurement (1383)

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

Event Date 09/21/2023

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.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, during use in patient with this swan-ganz catheter, inaccurate pressure values were displayed.It was displayed 11mmhg (systolic bood pressure)/-1mmhg (diastolic blood pressure)/5mmhg (mean pulmonary artery pressure) and, according to the patient's condition, the values should be 30/10/20 mmhg.The device was changed for another catheter and it was measured 25/8/15 mmhg.No error message nor alarm was displayed.The patient was not treated according to the incorrect values.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

The device was sent to our product evaluation laboratory for a full evaluation.As received, report of pressure issue was unable to be confirmed.All through lumens were patent without any leakage or occlusion.All through lumens passed pressure test with lab disposable pressure transducer (dpt).Balloon inflated clear and concentric, and remained inflated for 5 minutes.Further investigation was performed by the engineers in the manufacturing site.The complaint affected unit was returned for evaluation and no defect was found; therefore a product non-conformance or device failure could not be confirmed.The reported malfunction code could be associated to multiple root causes.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Additionally, as part of the manufacturing process the units go through a leak and flow test where all the catheter lumens patency is verified.The pulmonary capillary wedge pressure (pawp) is measured inflating catheter balloon.As per manufacturing process, the units go through a balloon inflation and visual inspection.Since a failure mode could not be confirmed, and with the information available further investigation could not be performed.

• Brand Name: SWAN-GANZ CATHETER
• 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: 17955245
• MDR Text Key: 325903642
• Report Number: 2015691-2023-16886
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231248
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 774F75
• Device Lot Number: 64599129
• 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: 12/11/2023
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 58 KG