MAUDE Adverse Event Report: MEDTRONIC, INC. FLEXCATH CROSS TRANSSEPTAL SOLUTION; INTRODUCER, CATHETER

Model Number	900301-003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of paroxysmal atrial fibrillation.Procedure: electrophysiology study with ablation.The needle of the medtronic flexcath cross sticks past the end of the sheath.It does not retract into the sheath.Product not used on patient.No known harm.

• Brand Name: FLEXCATH CROSS TRANSSEPTAL SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 19212337
• Report Number: 19212337
• Device Sequence Number: 6942253
• Product Code: DYB
• UDI-Device Identifier: 00850027837765
• UDI-Public: (01)00850027837765(11)231116(17)251114(10)105308
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/12/2024
• Report Date (Section F): 04/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: 900301-003
• Device Catalogue Number: 900301-003
• Device Lot Number: 105308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 105 KG
• Date Report Sent to FDA: 04/12/2024