MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM; CATHETER, FLOW DIRECTED

Model Number	ALTAALL1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.
Event or Problem Description
As reported, during this alta target market release (tmr) using a swan-ganz iq catheter, the dpdt rv value (111 mmhg/s) was much lower than the dpdt obtained using the echo to graph the waveform of the rv (699 mmhg/s).There was no allegation of patient injury.There will be no product return as this is a tmr.
Additional Manufacturer Narrative
Updated: b5 (event description), g6 (type of report), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions).Added: h2 (type of follow-up).The device of the reported complaint was not returned for evaluation; however, images and software logs were provided.Review of the provided images and software log confirmed normal device behavior.The appropriate error messages were displayed to warn the user that they would be unable to analyze boluses.The allegation of inaccurate rv values when compared to echo was unable to be confirmed, as there was no clinical data / echo data / timestamps provided to compare with the software log.The product non-conformance was unable to be confirmed as the product was not returned.There was no evidence of product non-conformance or labeling/ifu inadequacies identified.Based on the information obtained, the root cause of the alleged complaint was unable to be determined.The manufacturing records were reviewed and there is no indication of a related non-conformance; all process parameters were met, and inspections passed successfully.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.
Event or Problem Description
As reported, during this alta target market release (tmr) using a swan-ganz iq catheter, the dpdt rv value (111 mmhg/s) was much lower than the dpdt obtained using the echo to graph the waveform of the rv (699 mmhg/s).Additionally, thermodilution was tried to be completed but it remained on baseline calculation about 10 minutes and, after that, no values were provided.In the meantime, several error messages were displayed due to values out of limits.Furthermore, at the time of injecting the bolus, an error message saying that injectate temperature was not low enough was displayed, being that the bolus was cold.The issue was solved by moving the limits and clearing the alarms.There was no allegation of patient injury.

• Brand Name: HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22493448
• Report Number: 2015691-2025-05667
• Device Sequence Number: 17174027
• Product Code: DYG
• UDI-Device Identifier: 00690103217957
• UDI-Public: (01)00690103217957(11)240917
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242451
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: ALTAALL1
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown