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

Model Number 14F

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/06/2017

Event Type  Injury  

Event Description

Surgeon reports when he inserted the sheath, the valve appears to have failed and the patient began to hemorrhage.

• Brand Name: FAST-CATH
• Type of Device: HEMOSTASIS INTRODUCER
• Manufacturer (Section D): ST.JUDE MEDICAL; plymouth MN 55442
• MDR Report Key: 6405595
• MDR Text Key: 70079651
• Report Number: MW5068434
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 14F
• Device Lot Number: 4517423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR