MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTI CATH QUARTZ 65; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number PN-004065

Device Problems Break (1069); Device Displays Incorrect Message (2591)

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

Event Date 11/30/2015

Event Type  malfunction  

Event Description

The catheter was removed from the package and placed on the table as in normal preparation.The catheter was prepped as usual, it was then advanced into the right atrium, plugged into the tacti-cath unit at that time an error message appeared "no fiber optic cable connected".A second attempt was to unplug and retry the catheter, but it would not work.A new catheter was used and worked just fine (from the same lot number).A st jude rep was in the procedure so it was given to her.

• Brand Name: TACTI CATH QUARTZ 65
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane n; plymouth MN 55117
• MDR Report Key: 5385010
• MDR Text Key: 36611108
• Report Number: 5385010
• Device Sequence Number: 1
• Product Code: LPB
• 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: Other
• Type of Report: Initial
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/25/2017
• Device Model Number: PN-004065
• Device Lot Number: 5135379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO