MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number PN-004075

Device Problem Failure to Reset (1532)

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

Event Date 12/07/2015

Event Type  malfunction  

Event Description

It was a catheter malfunction.The staff was unable to reset the sensor pressure reading when connected the cable.The catheter was removed, and a new catheter was inserted and functioned well.The procedure completed successfully and no injury to the patient.

• Brand Name: TACTICATH
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st paul MN 55117
• MDR Report Key: 5305453
• MDR Text Key: 33720119
• Report Number: 5305453
• Device Sequence Number: 1
• Product Code: OAE
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2017
• Device Catalogue Number: PN-004075
• Device Lot Number: 5135401
• 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: 12/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 72 YR