MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2022

Event Type  malfunction  

Event Description

Flushed device with heparin saline and plugged into the system.When the catheter was plugged in, an error code presented as an: "electrical leak".Unplugging and plugging back in didn't solve the issue, so a new catheter was used.(lot# of new device 30793861l).

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 15715 arrow hwy; irwindale CA 91706
• MDR Report Key: 15300267
• MDR Text Key: 298675128
• Report Number: 15300267
• Device Sequence Number: 1
• Product Code: LPB
• 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: 08/19/2022,08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30793834L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1