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

Model Number 20000ISM

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2023

Event Type  Injury  

Event Description

Mitral clip procedure was being performed with edwards pascal precision transcatheter valve repair system.Experienced placement issues, attempted to deploy device.Device delivery system unable to disengage from mitral clip and attempted to disengage delivery system from clip but was unsuccessful.

• Brand Name: PASCAL PRECISION SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16156814
• MDR Text Key: 307273201
• Report Number: 16156814
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20000ISM
• Device Catalogue Number: 20000ISMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White