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 08/08/2022

Event Type  malfunction  

Event Description

As reported, during use of this swan ganz catheter, svo2 value on hemosphere monitor firstly showed 40 and drifted; however, svo2 value as per blood sampling is 70 (medwatch # 20673).Then, hemosphere monitor showed 67 and drifted; however, svo2 value as per blood sampling is 51 (medwatch # 20675).There was no error message displayed or alarm indicating that the svo2 signal was not good.Patient was not treated according to the incorrect values.There was no allegation of patient injury.Patient demographics unable to be obtained.The device was not available for evaluation as it was discarded.As a summary, two medwatch reports will be submitted (medwatch # 20673 and medwatch # 20675).

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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

Upon further clarification by the customer, the svo2 values provided by the swan-ganz catheter involved in this case was corrected to be 78 while blood sampling showed 49.An image was provided for examination.The image appeared to show a range of parameters including the reported dynamic svo2 values coming from the swan ganz catheter oximetry and the alleged inaccuracy relative to the corresponding blood gas analysis results at various time points.However, this inaccuracy cannot be confirmed using this image as the parameter label of each row being measured is not captured in the image.Based on further engineering investigation, the units go through optical attenuation 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.

• 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: 15507828
• MDR Text Key: 305883428
• Report Number: 2015691-2022-08162
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 110 KG