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

Model Number 777F8

Device Problems Deflation Problem (1149); Failure to Deflate (4060)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and 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.H3 other text : the product is expected to be returned for analysis; however, it has not yet been received.

Event Description

As reported, before use in patient and during the device preparation of this swan-ganz catheter, the balloon did not deflate by itself correctly, even if the syringe was removed/disconnected from the red lumen.After 15 times, the balloon could deflate, the first 14 tries, the balloon did not deflate completely.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Updated section h6 (device code) h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).Finally, the device was not received for evaluation.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.Based on further engineering investigation, the units go through a balloon inspection as part of the manufacturing process.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.

Manufacturer Narrative

Added information to section (lot number), (expiration date), (device manufacturer date) updated section (type of investigation), (investigation findings) and (investigations conclusions).The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Finally, the device was received for evaluation.The report of "balloon did not deflate" was not able to be confirmed.No visible damage or inconsistency was observed from catheter body or balloon.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without the syringe attached and it was within specification.Based on further engineering evaluation, it was verified that the units go through a balloon inspection as part of the manufacturing process.The ifu includes instructions to verify the integrity of the balloon.

• 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: 18204043
• MDR Text Key: 328898556
• Report Number: 2015691-2023-17723
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Lot Number: 64568149
• 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: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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: 65 YR
• Patient Sex: Male