MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FAST-CATH; INTRODUCER, CATHETER

Model Number	406804
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Dilator sheath "poking" through sheath, did not enter the patient's body.

• Brand Name: FAST-CATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11444265
• Report Number: 11444265
• Device Sequence Number: 19737641
• Product Code: DYB
• UDI-Device Identifier: 05414734203302
• UDI-Public: (01)05414734203302(17)230831(10)7664835
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/05/2021
• Report Date (Section F): 03/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: 406804
• Device Catalogue Number: 406804
• Device Lot Number: 7664835
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 91
• Date Report Sent to FDA: 03/05/2021