MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ TRIO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 12; INTRODUCER, CATHETER

Model Number	406306
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No corrective action will be implemented in this case.This type of reported event will continue to be monitored.
Event or Problem Description
During a paroxysmal supraventricular tachycardia procedure, when the sheath was removed from the patient, a blood leak was noted from the middle of the sheath.The sheath was inspected and a small crack was found on the sheath tubing.The procedure was completed without replacing the introducer and there were no adverse consequences to the patient.

• Brand Name: FAST-CATH¿ TRIO HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 12
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8577283
• Report Number: 3005334138-2019-00250
• Device Sequence Number: 1536989
• Product Code: DYB
• UDI-Device Identifier: 05414734203920
• UDI-Public: 05414734203920
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954317
• 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): 05/20/2019

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: 09/30/2021
• Device Model Number: 406306
• Device Lot Number: 6677543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1