MAUDE Adverse Event Report: ST. JUDE MEDICAL; TRANSEPTAL NEEDLE

Model Number 407200

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 05/01/2012

Event Type  malfunction  

• Type of Device: TRANSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau pl.; minnetonka, MN 55345
• MDR Report Key: 4853885
• Report Number: 4853885
• Device Sequence Number: 1
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2012

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
• Device Operator: Physician
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 3499317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1