MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. TACTICATH; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number QUARTZ 75

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2019

Event Type  malfunction  

Event Description

Tacticath opened and plugged into the machine.Machine had a red light that came on and at that point we opened another tacticath and it worked.Manufacturer response for tacticath, st.Jude medical, inc.(per site reporter).Return back to them and fix the issue.

• Brand Name: TACTICATH
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau pl.; minnetonka MN 55345
• MDR Report Key: 8403158
• MDR Text Key: 138214149
• Report Number: 8403158
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QUARTZ 75
• Device Catalogue Number: PN-004075
• Device Lot Number: 6612573
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1