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

Model Number 131F7P

Device Problem Incorrect Measurement (1383)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

The user could not assure the lot number involved, there are two potential lot numbers (65218481 / 65249973).Follow up is on going to clarify whether the device is available for evaluation.An investigation has been initiated to consider any potential factors that may have contributed to this complaint.A supplemental report will be forthcoming with the evaluation 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, the user perceived the co (cardiac output) measurements as unreasonable low (2.62 and 2.65 l).The device was switched to a cco (continuous cardiac output) catheter and the co measurement obtained was 3.83 l.There was no allegation of patient injury.

Manufacturer Narrative

Added: d4 (expiration date), h4 (device manufacturer date), h6 (type of investigation).Updated: h6 (component code, investigation findings, investigation conclusions).The user could not assure the lot number involved, there are two potential lot numbers.- lot number: 65218481 - h4 (device manufacturer date) 01/aug/2023 - d4 (expiration date) 30/jul/2025.- lot number: 65249973 - h4 (device manufacturer date) 06/aug/2023 - d4 (expiration date) 02/aug/2025.The device was not available for evaluation.Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.The manufacturing records were reviewed 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, it could be verified that all units go through an electrical inspection process.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.

• 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: 18391528
• MDR Text Key: 331672460
• Report Number: 2015691-2023-18753
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• 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: 65218481 / 65249973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• 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