MAUDE Adverse Event Report: MEDTRONIC, INC. FLEXCATH ADVANCE; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Failure to Advance (2524)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Unable to pass cryo ablator balloon through cryo sheath.Rf ablation performed.No harm to patient harm.Operative note: transseptal catheterization was completed with intracardiac echo and fluoroscopic guidance, and a guidewire was advanced into the left superior pulmonary vein; and initially i used a flex sheath, but i encountered issues with the sheath functionality and did not further complete cryoablation.Stat radiofrequency ablation (raf) was performed.Raf was performed by introduction of a 3.5 mm irrigated tip stsf catheter manufactured by biosense webster.

• Brand Name: FLEXCATH ADVANCE
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 12827723
• MDR Text Key: 280886359
• Report Number: 12827723
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/04/2021

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: 4FC12
• Device Lot Number: 0010818750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White