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

Model Number SMARTTOUCH D-F

Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

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

Event Date 04/12/2016

Event Type  malfunction  

Event Description

An ablation catheter was inserted into the body and zeroed.After it was zeroed there was a sensor error on the catheter.We tried unplugging and re-plugging the electrical cable with no success.The new catheter was handed off to physician.There was no further issue with the new catheter.A product rep with biosense webster called the catheter in.The catheter was a biosense webster thermocool smarttouch d-f cat # d132705 lot 17325496m the catheter did not zero and was given to return to biosense.No harm to the patient in this event.

• Brand Name: THERMOCOOL SMARTTOUCH
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 6002704
• MDR Text Key: 56576484
• Report Number: 6002704
• Device Sequence Number: 1
• Product Code: DRF
• 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: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: SMARTTOUCH D-F
• Device Catalogue Number: D132705
• Device Lot Number: 17325496M
• Other Device ID Number: 11176WI
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2016
• 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
• Patient Age: 47 YR