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

Catalog Number D134805

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

Patient Problem Ventricular Fibrillation (2130)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation could not be conducted because no lot number was provided by the customer.Manufacturer's ref.#: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered ventricular fibrillation (vfib) requiring cardioversion.During the procedure, when going into the right ventricle (rv) with the thermocool® smart touch® sf bi-directional navigation catheter, there was a right ventricular pacing lead for the patient¿s pacemaker.The pacemaker was turned off for the procedure.The physician checked intracardiac echo (ice) before starting ablation and believed the catheter to be in an adequate distance from the pacing lead.When the ablation started, all electrocardiogram (ecg) signals and map distal signals were lost, and the patient went into vfib.The ablation was immediately stopped, and all signals came back.Cardioversion was performed, and the patient went back into normal sinus rhythm.The case continued with no further issues.The patient was reported to be in stable condition.Despite reported signal loss that was observed in all ecg signals, it is not known if the signals were lost on all systems or if the signal loss caused the ecg signal to be discernable.It is standard practice to have multiple external systems to monitor the patient¿s ecg rhythm during these procedures.This mitigates the risk that the patient¿s ecg rhythm would be unobservable at any point during the procedure.As such, the issue of signal loss is considered to present low risk to the patient and not mdr reportable multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8947404
• MDR Text Key: 156455198
• Report Number: 2029046-2019-03593
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2019

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: D134805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/29/2019
• 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
• Patient Outcome(s): Life Threatening; Required Intervention