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

Model Number 20000IS

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Event Description

Edwards received notification of a pascal precision procedure in mitral position where no damage was noticed on syringe or steerable catheter stopcock.Aspiration of air was observed through the steerable catheter (sc) flushport as aspiration for connecting it to the pressure monitoring system was done.The sc was aspirated (1-2 times) but it was continued to see air.Around 20cc was aspirated.The sc was aspirated slowly, and blood was aspirated that looked foamy.It was then decided by the physician to proceed with the device and not to flush the sc as normally required and disconnected it from the pressure monitor line.No influence on patient was observed and there were no ekg abnormalities.Procedure was completed successfully without further incidences.

Manufacturer Narrative

The complaint for device not completely de-aired during flushing and preparation was confirmed with objective evidence.No manufacturing non-conformities were found in the returned sample.Available information suggests that the system my leak while aspirating with excessive pressure or while aspirating and pulling up on the syringe while the system is in the stabilizing rail system (srs).However, a definite root cause is unable to be determined.

• Brand Name: EDWARDS PASCAL PRECISION
• Type of Device: 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: 18791310
• MDR Text Key: 336363008
• Report Number: 2015691-2024-01386
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213317
• UDI-Public: (01)00690103213317(17)240824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Model Number: 20000IS
• Device Lot Number: 11154894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female