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 Cardiac Tamponade (2226)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient underwent cardiac ablation procedure for supreventricular tachycardia (svt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.It was reported that during an svt (this was a repeat vt ablation with scar on the septum), case, a pericardial effusion was noticed as the physician monitor using ultrasound.There were no visible signs on the patient and the effusion was monitored over 2hrs.The pericardial effusion was confirmed by intracardiac echo (ice).The medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed.After reviewing case information there was no force over 40 grams and no impedance value picking over the normal range.No errors were ever displayed and the physician believed that the effusion may had happened when the patient was cardioverted.The patient was reported to be in stable condition.No cardiac arrest occurring during the procedure.The effusion occurred after ablation.The physician believed the effusion occurred around the time of cardioversion.He believed a catheter could have caused the effusion from the force of cardioversion.When the drain was removed the effusion had to be drained again.The patient was reported to be doing well.Draining the effusion was sufficient.There was no evidence of steam pop.There were no findings of a steam pop.Flow rates were 2ml/min for low flow and 8.15 ml/min for high flow.There were no error messages.Force visualizations were graph, dashboard, vector, and vizitag.Vizitag settings were range: 4mm for time: 3 seconds and 25% force over time for 3g.Color bar was set to impedance drop from 3-10.It is unknown whether extended hospitalization was required.

Manufacturer Narrative

It was reported that a male patient underwent cardiac ablation procedure for supreventricular tachycardia (svt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.It was reported that during an svt (this was a repeat vt ablation with scar on the septum), case, a pericardial effusion was noticed as the physician monitor using ultrasound.There were no visible signs on the patient and the effusion was monitored over 2hrs.The pericardial effusion was confirmed by intracardiac echo (ice).The medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed.No errors were ever displayed and the physician believed that the effusion may had happened when the patient was cardioverted.The patient was reported to be in stable condition.Device evaluation details: on 1/6/2021, the bwi product analysis lab received the complaint device for evaluation and the evaluation has been completed.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, and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The device instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 11085053
• MDR Text Key: 224384476
• Report Number: 2029046-2020-01997
• 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: 12/01/2020

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: 08/31/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30430805M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM
• Patient Outcome(s): Life Threatening; Required Intervention