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

Model Number QUARTZ 65

Device Problems Connection Problem (2900); Device Sensing Problem (2917)

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

Event Date 12/13/2017

Event Type  malfunction  

Event Description

Catheter was removed from package and prepped accordingly, but when the catheter was plugged into the system the distal electrograms were not visible, and nor would they show up on the mapping system.It was un plugged and tried again but still wouldn't work.Another one was used and worked fine (lot #5778446).

• Brand Name: TACTICATH¿
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; saint paul MN 55117
• MDR Report Key: 7159719
• MDR Text Key: 96228199
• Report Number: 7159719
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/25/2019
• Device Model Number: QUARTZ 65
• Device Catalogue Number: PN-004065
• Device Lot Number: 6031304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2017
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR