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

Model Number	831F75
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the swan-ganz catheter, there was a pinhole sized leak below one of the ports.The catheter was exchanged for a new one.There was no patient injury.
Additional Manufacturer Narrative
Additional fda product codes include: dqo- catheter, intravascular, diagnostic dqe- catheter, oximeter, fiberoptic kra- catheter, continuous flush dqk- computer, diagnostic, programmable drs- transducer, blood-pressure, extravascular dsb- plethysmograph, impedance dxn- system, measurement, blood-pressure, non-invasive qaq- adjunctive predictive cardiovascular indicator.One model 831f75 catheter with monoject limited volume syringe and non-edwards contamination shield was returned for evaluation.The customer report of leakage was confirmed.Visual examination found that proximal injectate extension tube was partially broken at the lumen hub.Cross surface of the broken extension tube appeared to be uneven and rough.Distal lumen was occluded with blood.Infusion lumen was patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No other visible damage was observed from catheter.A supplemental report will be forthcoming when the engineering evaluation is completed.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.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available evidence, it was identified that the assembly of the components where the leakage occurs is not manufactured internally in the dominican republic bd apm manufacturing process.The affected assembly is manufactured by edwards puerto rico.Consequently, this is a supplier related condition, and the corresponding supplier notification was sent.The lot number was not provided thus a device history record was not reviewed.As part of the manufacturing process 100% of the units undergo a leak and flow test and a visual inspection.

• Brand Name: SWAN-GANZ VIP
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): BD APM; 17200 laguna canyon rd; irvine CA 92603
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23416458
• Report Number: 2015691-2025-08919
• Device Sequence Number: 8945503
• Product Code: DYG
• UDI-Device Identifier: 00690103003031
• UDI-Public: 00690103003031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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 Model Number: 831F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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