MAUDE Adverse Event Report: Edwards Lifesciences PR SWAN-GANZ VIP+; CATHETER, FLOW DIRECTED

Model Number	834F75
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the swan ganz catheter, it provided high cvp values.The catheter was placed in the or shortly before the inaccurate values were seen in the unit.After re-zeroing and troubleshooting the cvp transducer, the cvp line was moved to the double lumen central venous catheter (cvc) and the reading there was an expected value.There were microcracks in the blue lumen at the connection with the proximal injectate lumen.The rn was still able to check thermodilution utilizing the blue pa line but monitored cvp on double lumen cvc instead.There was no allegation of patient injury.
Additional Manufacturer Narrative
Additional fda product codes include: dqe- catheter, oximeter, fiberoptic.Dqo- catheter, intravascular, diagnostic.Kra- catheter, continuous flush.The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation 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.

• 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 ; PR
• Manufacturer (Section G): BD APM; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; +1(949)201-7706
• MDR Report Key: 50820264
• Report Number: 2015691-2026-18678
• Device Sequence Number: 21370420
• Product Code: DYG
• UDI-Device Identifier: 00690103151756
• UDI-Public: 00690103151756
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 834F75
• Was Device Available for Evaluation?: Yes
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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