MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿SR0¿; INTRODUCER, CATHETER

Model Number	406844
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, blood was leaking from the introducer.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
Event or Problem Description
During an atrial fibrillation procedure, blood was leaking from the introducer.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event of leak could not be confirmed.The sheath passed pressure and aspiration leak testing with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• Brand Name: FAST-CATH¿ GUIDING INTRODUCER SWARTZ¿SR0¿
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8154712
• Report Number: 3005334138-2018-00488
• Device Sequence Number: 16515819
• Product Code: DYB
• UDI-Device Identifier: 05414734202930
• UDI-Public: 05414734202930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061015
• 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,Followup
• Report Date (Section B): 01/22/2019

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: No Information
• Device Expiration Date: 04/30/2021
• Device Model Number: 406844
• Device Lot Number: 6450561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 12/19/2018; 01/18/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 12/19/2018; 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1