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

Model Number	831F75
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	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patients central venous pressure (cvp) increased from 6 to 22 mmhg.The cvp line was flushed and checked for blood return.No blood return noted, medications came back into syringe.There was no allegation of patient injury.Device is available for return.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.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.The following are additional product codes for this device: dqo: catheter, intravascular, diagnostic.Dqe: catheter, oximeter, fiberoptic.Kra: catheter, continuous flush.
Additional Manufacturer Narrative
Our product evaluation lab received one model 831f75 catheter with a non-edwards contamination shield.The customer report of inaccurate values were unable to be confirmed.A kink was observed from the catheter at 92cm from tip.All through lumens were patent and did not leak.Catheter passed pressure test with lab dpt.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.An engineering evaluation was completed to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect since the device failure was not able to be confirmed.As part of the manufacturing process, 100% of the units go through visual inspection.The ifu also indicates the following regarding catheter preparation: flush catheter lumens with a sterile solution to ensure patency and to remove air.*pending dhr review completion* 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
• Manufacturer (Section G): EDWARDS LIFESCIENCE IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 20081807
• Report Number: 2015691-2024-06654
• Device Sequence Number: 7562065
• Product Code: DYG
• UDI-Device Identifier: 00690103003031
• UDI-Public: 00690103003031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K810352
• 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): 11/04/2024

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 Model Number: 831F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 11/04/2024
• 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