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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 11/23/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.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 71 year old female patient weighing 130.0 lbs.Underwent an atrial flutter right (r-afl) ablation procedure thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a heart block.It was reported by the bwi representative that at the beginning of a procedure when the smarttouch sf catheter was plugged in and received error code: 40 "map defective catheter or cable", error code: 105 "map catheter sensor error", error code: 41 "ref/deca defective catheter or cable", error code 42 "20-pole a defective catheter", error code: 43 "20-pole b defective catheter, and error code: 44 "ultrasound system defective catheter or cable".To troubleshoot , the bwi representative unplugged the ablation catheter without resolution.They then rebooted the carto 3 system without the catheter plugged in and the issue was temporarily resolved.They plugged the smarttouch sf catheter back in and "error code: 401 catheter sensor error" appeared on the carto 3 system.They tried swapping the cable without resolution.They replaced the catheter, the issue was resolved, and the procedure continued.The bwi representative stated that it was the physician's opinion that there was an issue with " the conducting system." they are requesting a replacement smarttouch sf catheter and documenting an adverse event for the second catheter used.They were advised to expect a return kit and both catheters are available for return.The bwi representative reported that when ablation was completed during the procedure and the catheter was being moved into the ventricle, they experienced a "complete heart block".Type of injury- complete heart block.It was discovered "based off the intracardiac" as the catheter was moved there were no "v signals.".As the catheter was moved there were no "v signals." on both the carto 3 system and the "on the cardio lab." they put a catheter into the right ventricle and paced that for 30 minutes while putting the patient on isoprel.This did not resolve the complication.The patient was then put on a temporary pacemaker.The patient is now stable with the temporary pacemaker.Type of case- left and right atrial flutter.Part of a clinical study-no.The adverse event occurred on (b)(6) 2022.The adverse event was discovered when our stsf catheter was in the body and was moving into the tricuspid valve, but rf was not being used.Physician¿s opinion on the cause of this adverse was the patient condition.Patient was warned prior to case start that her conduction system was incredibly weak, and stress may cause it to fail.Intervention provided was isoproterenol at high dosage and ventricular pacing, originally off of stsf then switched to a quad.After 30+ min of conduction not returning a temporary pacemaker was placed.Outcome of the adverse event was unchanged.She is scheduled to have a permanent pacemaker implanted today.Patient required extended hospitalization because of the adverse event due to temporary pacemaker and waiting for permanent pacemaker she stayed an extra day.Other relevant history-pt.Had a prior cti and afib ablation, during which it was determined her conduction system was quite weak.Pt prior to any ablation had left bundle branch block of unknown origin.The only bwi catheter in the body was the stsf.Other catheters in the body were a jsn quad in the rv, and a cs inquiry ij catheter.Both stsf catheters, the one that malfunctioned and the one from the adverse event, are available for return.Generator information- sn: (b)(4).Patient regained conduction before friday morning and pacemaker was cancelled.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 20-jan-2023, the product investigation was completed.It was reported that a 71 year old female patient weighing 130.0 lbs.Underwent an atrial flutter right (r-afl) ablation procedure thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a heart block.It was reported by the bwi representative that at the beginning of a procedure when the smarttouch sf catheter was plugged in and received error code: 40 "map defective catheter or cable", error code: 105 "map catheter sensor error", error code: 41 "ref/deca defective catheter or cable", error code 42 "20-pole a defective catheter", error code: 43 "20-pole b defective catheter, and error code: 44 "ultrasound system defective catheter or cable".To troubleshoot , the bwi representative unplugged the ablation catheter without resolution.They then rebooted the carto 3 system without the catheter plugged in and the issue was temporarily resolved.They plugged the smarttouch sf catheter back in and "error code: 401 catheter sensor error" appeared on the carto 3 system.They tried swapping the cable without resolution.They replaced the catheter, the issue was resolved, and the procedure continued.Device evaluation details: visual analysis revealed damage in the shaft near the handle.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested.In addition, the product was deflecting correctly.The catheter was not irrigating correctly due to the damage observed on the shaft.A manufacturing record evaluation was performed for the finished device 30912462l number, and no internal action related to the complaint was found during the review.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16016542
• MDR Text Key: 305840397
• Report Number: 2029046-2022-03198
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30912462L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 59 KG