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

Model Number 4FC12

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 01/28/2022

Event Type  malfunction  

Event Description

Dilator unable to seat in catheter, not in patient's body, no harm or injury to pt.Utilized a new sheath w/o issues.

• Brand Name: FLEXCATH ADVANCE
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 13440319
• MDR Text Key: 285063816
• Report Number: 13440319
• 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: 02/01/2022,02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• 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: 0010869891
• 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: 02/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White