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

Model Number 131F7P

Device Problem Incorrect Measurement (1383)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

As reported, during a study performing cardiac output and cardiac index (co/ci) measurements from this ico based swan-ganz catheter via philips adaptor, the ci measurement was inaccurate.The value provided by the swan-ganz was 1.0l/min/m2.The measurement was not compared with any other method.No treatment was provided based on inaccurate values.There was no allegation of patient injury.The device was not available for evaluation.

Manufacturer Narrative

The user could not assure the lot number involved, there are two potential lot numbers (64964009 and 64848603).For lot 64964009, device manufacturer date (h4): 2023/04/20 and expiration date (d4): 2025/04/16.For lot 64848603, device manufacturer date (h4): 2023/01/02 and expiration date (d4): 2025/01/31.The manufacturing records were reviewed for both potential lot numbers involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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.Based on further engineering investigation, as part of the manufacturing process, all the units go through an electrical inspection 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 THERMODILUTION 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: 18063611
• MDR Text Key: 327749368
• Report Number: 2015691-2023-17236
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7P
• Device Lot Number: 64848603 / 64964009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2023
• 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 Weight: 82 KG