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

Model Number	834F75
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section d9, h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Section b5 was reworded to: as reported, when trying to remove this swan ganz catheter inserted in a patient with already high pa (pulmonary artery) pressure due to user suspicion of device coiling in the right atrium, this swan ganz catheter balloon did not deflate.Once the product was withdrawn, the balloon appeared to be inflated and half-filled with a clear fluid of unknown origin, despite it had been tried to be deflated manually and a toe probe (trans-oesophageal echocardiogram) was utilized to make sure the balloon was not inflated before catheter removal.Before insertion, the catheter had been ushed and the balloon inflated and deflated passively without problems.Also, upon insertion into patient, the balloon inflated smoothly.There was no patient injury and a new swan ganz catheter was inserted.The device was evaluated.The report of could not be deflated was unable to be confirmed.As received, balloon was intact but could not maintain inflation due to an interlumen leakage between the distal and optical lumen.Interlumen leakage occurred in the catheter backform.Through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.The reported issue could not be confirmed.The additional issue, that was not related to the initial problem, was concluded to be potentially related to the manufacturing process.As part of the manufacturing process, the units go through a leak test inspection process and a balloon inflation.
Event or Problem Description
As reported, once this swan-ganz catheter was inserted into patient, it could not be deflated.Before insertion, the catheter was flushed and the balloon tested successfully.The balloon inflated easily and deflated passively.Upon insertion to patient, the balloon inflated smoothly.Before floating, the pa (pulmonary artery) pressure was registering a high reading already.The catheter was floated but the user thought it was coiling in the right atrium, so it was decided to remove the catheter.However, the balloon did not deflate passively.The balloon was tried to be deflated manually as per consultant anesthetist's instructions.The toe probe (trans-oesophageal echocardiogram) was utilized to make sure the balloon was not inflated before withdrawing, but it was finally removed with the balloon inflated without any issues.Once removed, the balloon appeared to be inflated and half-filled with a clear fluid of unknown origin.The problem was solved using a new swan-ganz catheter.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
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.

• Brand Name: SWAN-GANZ CATHETER
• Common Device Name: 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: 20912113
• Report Number: 2015691-2024-09491
• Device Sequence Number: 18259223
• Product Code: DYG
• UDI-Device Identifier: 00690103151756
• UDI-Public: (01)00690103151756(17)251219(11)231220(10)65457404
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2025
• Device Model Number: 834F75
• Device Lot Number: 65457404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 84 KG