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

Model Number 831F75P

Device Problems Signal Artifact/Noise (1036); Incorrect Measurement (1383); Gas/Air Leak (2946)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

As reported, during use in patient with this swan-ganz catheter, the measurements provided were incorrect; therefore, the device was withdrawn.The balloon had been tested before insertion and it could be inflated.After device withdrawal, the balloon was re-tested.The balloon was inflated but it deflated slowly despite the syringe was blocking the system.The device was exchanged and the operation was completed without any problem.No further information was available.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Patient demographics unable to be obtained.One swan-ganz catheter was received by our product evaluation laboratory for a full examination.The evaluation is ongoing.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.

Manufacturer Narrative

Based on further information received the curve provided by the swan-ganz catheter involved in this event was damped.Therefore, the device was not used to measure and was replaced for another one.An abnormal waveform alerts the clinician to a problem with the catheter.If unable to resolve the issue, the catheter can be exchanged with a minimal delay in treatment or monitoring.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• 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: 18265175
• MDR Text Key: 329669087
• Report Number: 2015691-2023-17924
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 831F75P
• Device Lot Number: 65056416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 66 YR