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

Model Number D134701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent cardiac ablation procedure for paroxysmal atrial fibrillation with thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.It was reported that the ultrasound system was not recognizing the soundstar catheter when it was connected to the ultrasound machine (s70).The catheter was replaced, and the issue was resolved.The procedure was continued.The caller stated that the carto 3 system is operating per specs and is not responsible for the product issue and that the catheter has been determined to be the root cause of the complaint reported.It was also reported that the patient suffered a pericardial effusion.The caller stated that the patient¿s blood pressure dropped.The ice catheter was used to confirm a pericardial effusion.A pericardiocentesis was performed and about 850 ml of fluid was removed from the pericardial space, with approximately 770 ml auto-transfused back to the patient.When the physician checked on the patient a while later, the patient was still hypotensive, and was sent to the or for a pericardial window.Caller states there was a baseline effusion present at the start of the case.Caller stated that 50 watts was used during the procedure.Surpoint visitag settings were used: 3 mm, 3 secs, 25% @ 3 gms, targeting a tag index of 600 on the lateral la.Approximately 45 minutes of rf time.While ablating at the lateral la wall, an impedance drop of approximately 30 ohms was noted.No steam pop noted.Physician is not sure of the cause of the effusion.The event was discovered post use of biosense webster products after ablation was performed and during ablation phase.The patient outcome is fully recovered.The irrigation settings were default flow settings for thermocool® smart touch® sf uni-directional navigation catheter.There were no error messages observed on biosense webster equipment during the procedure.Graph, dashboard, vector and visitag were all used for force visualization.The visitag settings were 3sec time, 3mm position, and 25% of force over 3g.No color options were used prospectively.There was no report of extended hospitalization.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation was completed on 10/9/2020.It was reported that a patient underwent cardiac ablation procedure for paroxysmal atrial fibrillation with thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a pericardial effusion.The caller stated that the patient¿s blood pressure dropped.The ice catheter was used to confirm a pericardial effusion.A pericardiocentesis was performed and about 850 ml of fluid was removed from the pericardial space, with approximately 770 ml auto-transfused back to the patient.When the physician checked on the patient a while later, the patient was still hypotensive, and was sent to the or for a pericardial window.Caller states there was a baseline effusion present at the start of the case.The event was discovered post use of biosense webster products after ablation was performed and during ablation phase.The patient outcome is fully recovered.There were no error messages observed on biosense webster equipment during the procedure.There was no report of extended hospitalization.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 instructions for use 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 reference number:(b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-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: 10577441
• MDR Text Key: 215964172
• Report Number: 2029046-2020-01317
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2021
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30380048M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SOUNDSTAR ECO GE 10F CATHETER; UNKNOWN BRAND CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR