MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PASCAL PRECISION; MITRAL VALVE REPAIR DEVICES

Model Number	20000GSA
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
Event or Problem Description
Edwards received notification of a pascal in mitral position where it was reported that a higher amount of bubbles were noticed being introduced into the la when advancing the steerable/implant catheters into the la.A new guide sheath was used and the procedure was completed successfully.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6 and h11.The complaint for inadequate aspiration, air remaining in device during insertion was confirmed with objective evidence via visualization of air in returned imaging.Follow-up communications with the clinical specialist noted continuous air drawn into the syringe while aspirating the gs during device preparation, as well as a large amount of air aspirated during procedure.However, as the product was not returned for evaluation, this is unable to be confirmed.The complaint was confirmed; however no manufacturing non-conformities could be confirmed.Potential root causes may include leak or other associated defect with the device, omission of a flushing/de-airing step or errors in performing steps, improper stopcock/syringe technique, or air from an alternative non-pascal device, fluid line, or procedural step.However, a definite root cause is unable to be determined.Furthermore, the device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances were identified.

• Brand Name: EDWARDS PASCAL PRECISION
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 21000945
• Report Number: 2015691-2024-09945
• Device Sequence Number: 9850451
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)250626
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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 Expiration Date: 06/26/2025
• Device Model Number: 20000GSA
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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: Male