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

Model Number	131F7P
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during testing this swan ganz catheter, the balloon did not deflate at all.There was no allegation of patient injury.Patient demographics were requested and unable to be obtained.
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.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Patient demographics unable to be obtained.Finally, no product was returned for evaluation despite various attempts.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.As part of the manufacturing process a balloon inspection is performed for the units and free deflation time requirements are established for all models.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20680974
• Report Number: 2015691-2024-08611
• Device Sequence Number: 12570100
• Product Code: DYG
• UDI-Device Identifier: 50690103000400
• UDI-Public: (01)50690103000400(17)260111(11)240112(10)65541043
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 01/11/2026
• Device Model Number: 131F7P
• Device Lot Number: 65541043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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 Sex: Unknown