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

Model Number	406124
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the valve on the introducer was leaking blood.Another introducer was used to complete the procedure with no patient consequences.
Additional Manufacturer Narrative
The reported event of a leak was confirmed.A leak was noted at the sideport tubing during functional testing.Further analysis revealed that there was sufficient solvent on the sideport tubing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The reported leak was determined not to be manufacturing related, however, due to the condition of the returned product and the information received, the cause of the reported leak remains unknown.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8579714
• Report Number: 3005334138-2019-00226
• Device Sequence Number: 13849670
• Product Code: DYB
• UDI-Device Identifier: 05414734014052
• UDI-Public: 05414734014052
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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 Expiration Date: 11/30/2021
• Device Model Number: 406124
• Device Catalogue Number: 406124
• Device Lot Number: 6765758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1