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

Model Number	831F75P
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: dqo, dqe, kra, dqk, drs, dsb, dxn, qaq.Additional premarket submission: k231248.Device is not available for return.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.However, an engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the reported lot number.A supplemental report will be forthcoming once the engineering evaluation is complete.Per the instruction for use, the catheter should remain indwelling only as long as is required by the patient's condition.The incidence of complications increases significantly with indwelling periods longer than 72 hours.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 a part of the monthly review.
Event or Problem Description
It was reported that, during use, a swan ganz catheter had saline and medication leak at the cvp port, where the white cap joins the blue tubing.Leakage occurred 5 days after use.Catheter was removed as the staff was unable to use the port.Lot number may be 66225267 as this was the remaining lot on the shelf.There were no patient injuries, but patient may have had a new swan inserted.
Additional Manufacturer Narrative
The device history record review was completed and the product passed without nonconformances.The product was not returned, however an image evaluation was completed on the provided photo and video.The reported event of "leakage" was confirmed.Leakage appeared to occur at proximal injectate hub and extension tube area.During the execution of the engineering evaluation process, it was identified that the assembly of the components where the leakage occurs is not manufactured internally in the manufacturing process.Consequently, this is a supplier related condition, and the corresponding supplier notification was sent through mail by the quality team.

• Brand Name: SWAN-GANZ VIP
• 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 LIFESCIENCE; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 22857166
• Report Number: 2015691-2025-06868
• Device Sequence Number: 20766532
• Product Code: DYG
• UDI-Device Identifier: 00690103218282
• UDI-Public: (01)00690103218282(17)270116(11)250116(10)66225267
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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
• Device Model Number: 831F75P
• Device Lot Number: 66225267
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• 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