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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure using a thermocool® smart touch® sf bi-directional navigation catheter.During the procedure, the patient experienced heart block that required pacemaker implantation and prolonged hospitalization.First, there was excessive noise displayed on the ablation distal signals, on the carto 3 and recording system.It was also reported that the smartablate generator displayed a "high impedance" error message, and there was no impedance reading displayed on the carto 3 system.The grounding pads were properly placed and connected.The smarttouch sf catheter connections were re-seated without resolution.The cable was replaced without resolution.The smarttouch sf catheter was replaced, and the issue resolved.The procedure continued.Then, during an atrial fibrillation case, a complete heart block was noticed in the patient, noticed on 12 lead ecg.The smarttouch sf catheter was immediately moved to the left ventricle for stable pacing.The procedure was stopped and a coronary sinus (cs) catheter was placed in the right ventricle for pacing, and the smarttouch sf catheter was removed from the body.A pacemaker was implanted.Additional information was received, and it was reported that the physician¿s opinion on the cause of this adverse event was that it was procedure related.The patient¿s intrinsic conduction recovered but the physician implanted the pacemaker anyway.Patient stayed overnight in the hospital and fully recovered (no residual effects).The noise issue is not mdr reportable as the risk to the patient is low.The high impedance issue, as well as the no impedance reading, were assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

• 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: 18294047
• MDR Text Key: 330069800
• Report Number: 2029046-2023-02894
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NGEN CONSOLE.; THMCL SMTCH SF BID, TC, D-F.; UNK BRAND CABLE.; UNK BRAND CABLE.; UNK CORONARY SINUS (CS) CATHETER.; UNK_CARTO 3.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male