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

Model Number 131F7

Device Problem Deflation Problem (1149)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

As reported, before use in patient, when testing, with this swan-ganz catheter, the balloon could not be deflated.The device was replaced with a new unit.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Patient demographics unable to be obtained.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.

Manufacturer Narrative

Updated: h3 (device evaluated by manufacturer), d9 (device availability), h6 (component code, type of investigation, investigation findings, investigation conclusions).Added: d4 (expiration date), h4 (device manufacturer date).The swan ganz catheter was received at our product evaluation laboratory for a full evaluation.Balloon did not maintain inflation due to interlumen leakage.Interlumen leakage was found between the balloon inflation lumen and the distal lumen in the backform.No visible damage was observed from the balloon.All other through lumens were patent without any leakage or occlusion.Report of "balloon could not be deflated" was unable to be confirmed.Further evaluation was completed by the engineers in the manufacturing site.A potential root cause for the interlumen leakage is associated to the manufacturing process, however, based on the information available a root cause could not be determined during the investigation.As part of the manufacturing process, units go through a leak test inspection process.In addition, to the leak test inspection, as part of the manufacturing process a balloon inflation inspection is performed to the manufactured units.The manufacturing personnel has been notified about this condition.

• 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: 18226095
• MDR Text Key: 329194778
• Report Number: 2015691-2023-17763
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7
• Device Lot Number: 65046143
• 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: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2023
• 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