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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Vasoconstriction (2126); Ischemic Heart Disease (2493)

Event Date 04/05/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 patient underwent a paroxysmal supraventricular tachycardia procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered an arterial spasm and a electrocardiogram st segment elevation.It was reported that it was a psvt 2nd session.At the 1st procedure, arrhythmia was not induced, and the procedure completed by eps (electrophysiology study ) only.This is the 2nd time, and it was diagnosed as slow-fast nrt.Timing was during sr, ra was mapped with octaray and the pivot point in sp region was ablated at 25w.After several ablation, performed eps and there were 2 echo, so tried to continue ablating, there was a physical movement of a patient, so the procedure was temporarily interrupted and sedated.When attempted to resume the procedure, about 10 minutes after the last ablation, st elevation was seen in the inferior wall, so the procedure was discontinued.St elevation was suspected due to spasm, cag was performed, diagnosed 4av obstruction.Attempted to unblock the obstruction with a wire, but no effective.Performed percutaneous coronary intervention (pci) and admitted to icu.Description of health hazard, spasm(4av).Progress: currently recovering but still in icu as a precaution physician's opinion on the relationship between this event and the product was that there may have been some effect of ablation, but the direct causal relationship was unknown.History/treatment/other diseases currently under treatment, etc., clinical examination details and results_4av obstruction, performed pci (percutaneuous coronary intervention) and unblocked the obstruction." the procedure was completed without patient's consequence.The complaint product(s) will not be returned for analysis.The adverse event occurred on (b)(6) 2023.It was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was the procedure.The physician commented that there may have been some effect of ablation, but the direct relationship was unknown.Percutaneous cornary intervention (pci) was performed for 4av obstruction.Outcome of the adverse event was recovered.The patient has now recovered but is hospitalized in icu as a precaution.Patient required extended hospitalization because of the adverse event as the patient is hospitalized in icu for follow-up.Relevant tests/laboratory data ---obstruction at 4av.Thermocool® smarttouch® sf catheter was used.Dashboard; vector; visitag were used.Additional filter used with the visitag was fot.Tag index was used.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.

• 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: 16846446
• MDR Text Key: 314316503
• Report Number: 2029046-2023-00933
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: NO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2023
• 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
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO VISITAG MODULE; OCTARAY CATHETER; SOUNDSTAR CATHETER; UNSPECIFIED GENERATOR; VIZIGO SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 11 YR