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

Catalog Number D134702

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 02/14/2024

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 ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrioventricular reentrant tachycardia (avnrt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the patient experienced av block that required temporary pacemaker.It was reported that while ablating the slow pathway for avnrt, the patient inhaled deeply which caused the catheter to move, resulting in complete heart block.The heart block, atrioventricular (av) disassociation, was noticed on ekg.The patient was receiving a temporary pacemaker at the time of the call and they will be monitored overnight.The caller stated that if av conduction does not return by tomorrow they "assume" a permanent pacemaker will be implanted.Additional information was received indicating the physician¿s opinion on the cause of this adverse event was the catheter movement during ablation.A temporary pacer was placed and then a pacer implant was performed for intervention.Patient improved (received a device).Patient required extended hospitalization.Needed to be observed overnight with temp pacer to see if normal sinus rhythm (nsr) would return; it did not so a pacer was implanted.

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular reentrant tachycardia (avnrt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the patient experienced av block that required temporary pacemaker.It was reported that while ablating the slow pathway for avnrt, the patient inhaled deeply which caused the catheter to move, resulting in complete heart block.The heart block, atrioventricular (av) disassociation, was noticed on ekg.The patient was receiving a temporary pacemaker at the time of the call and they will be monitored overnight.The caller stated that if av conduction does not return by tomorrow they "assume" a permanent pacemaker will be implanted.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31210924l and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On (b)(6) 2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular reentrant tachycardia (avnrt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the patient experienced av block that required temporary pacemaker.It was reported that while ablating the slow pathway for avnrt, the patient inhaled deeply which caused the catheter to move, resulting in complete heart block.The heart block, atrioventricular (av) disassociation, was noticed on ekg.The patient was receiving a temporary pacemaker at the time of the call and they will be monitored overnight.The caller stated that if av conduction does not return by tomorrow they "assume" a permanent pacemaker will be implanted.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation and the evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal action were identified.No malfunction was observed during the product analysis.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) contain the following warning and precautions: when using the catheter with conventional systems (using fluoroscopy to determine catheter tip location), or with the carto¿ 3 system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.The firmness of the braided tip dictates that care must be taken to prevent perforation of the heart.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 UNI-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: 18843169
• MDR Text Key: 336957526
• Report Number: 2029046-2024-00740
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2024

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 Catalogue Number: D134702
• Device Lot Number: 31210924L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/16/2024; 04/03/2024; Not provided
• Supplement Dates FDA Received: 03/18/2024; 04/09/2024; 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2024
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female