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	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during this target market release (tmr) on a tricuspid valve and mitral valve reconstruction with left atrial appendage closure procedure of this hemosphere alta monitor, the second time the ico and corv were measured, the ico was 3.4 and the corv 1.8.There was no error messages displayed.The patient was not treated according to the inaccurate values provided.Patient demographics were not available.There was no allegation of patient injury.There will be no product return as this is a tmr.
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 target market release (tmr) on a tricuspid valve and mitral valve reconstruction with left atrial appendage closure procedure of this hemosphere alta monitor, the second time the ico and corv were measured, the ico was 3.4 and the corv 1.8.In addition, after valve reconstruction, the ventricular waveform was a bit different than before, not wrong.Sales rep thinks the valve reconstruction event was what had an impact on the waveform.There were no error messages displayed.The patient was not treated according to the inaccurate values provided.There was no allegation of patient injury.There will be no product return as this is a tmr.
Additional Manufacturer Narrative
Updated: b5 (description event), g3 (date received by manufacturer), g6 (type of report), h6 (component code, investigation findings, investigation conclusions).Added: h2 (type of follow-up).The device of the reported complaint was not returned for evaluation, however, logs were provided.Based on r&d log investigation, the logs provided had insufficient information to confirmed the allegation of ico vs corv.However, there's no indication of any issue with measurement process per diagnostic logs provided.Based on further engineering investigation, the reported event was unable to be confirmed.Based on the available information, r&d was unable to replicate the inaccurate values.As the complaint could not be confirmed the purpose of the root cause analysis is to determine if the device related issue resulted from: incorrect/inadequate labeling/ifu/training manual, use error, or patient/procedural factors.Based on the voice of customer (voc) and the fact that r&d investigation did not find any device defect there is not sufficient evidence to suggest that the device related issue resulted from any of the specified factors.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.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.

• 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: 22747835
• Report Number: 2015691-2025-06442
• Device Sequence Number: 18292348
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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