MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure and developed thrombosis requiring no interventions.During the procedure clot formation on the distal tip and the electrode of the thermocool® smart touch® sf bi-directional navigation catheter was noticed.The issue was confirmed via ultrasound.The catheter was removed from the left atrium (la) and then removed from the patient¿s body.The patient was reported in stable condition and was monitored for any signs of a stroke.Stroke assessment was done, and no stroke was confirmed.Reminder of the procedure was aborted.There¿s no indication that any intervention or prolonged hospitalization were required.No error messages nor temperature or flow issues were reported.The generator was used in power control mode at 30 watts.The noted parameters were temperature at 32 degrees and impedance at 127 ohms.Patient was anticoagulated during the case, the activated clotting time (act) was monitored every 15 minutes and maintained until the case was cancelled.The duration of the ablation was not greater than 60 seconds.Standard irrigation settings were used throughout the case.The pre-ablation high setting was 2 ml.Heparinized normal saline was used as irrigation fluid.The visitag tag size was og 2mm.Time was used as coloring option.Thrombus/clot found inside of the patient is mdr-reportable.

Manufacturer Narrative

On 2/17/2021, bwi received additional information indicating that the patient was female.Additionally, the product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure and developed thrombosis requiring no interventions.During the procedure clot formation on the distal tip and the electrode of the thermocool® smart touch® sf bi-directional navigation catheter was noticed.The issue was confirmed via ultrasound.The catheter was removed from the left atrium (la) and then removed from the patient¿s body.The patient was reported in stable condition and was monitored for any signs of a stroke.Stroke assessment was done, and no stroke was confirmed.Reminder of the procedure was aborted.There¿s no indication that any intervention or prolonged hospitalization were required.Device evaluation details: the device was visually inspected, and it was found in good conditions.The magnetic, temperature and force features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device [30457843m] number, and no internal actions related to the reported complaint condition were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11331187
• MDR Text Key: 232364113
• Report Number: 2029046-2021-00180
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30457843M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Patient Outcome(s): Other