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 Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)

Event Date 05/23/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an afib - paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a junctional rhythm and hypotension.It was reported that junctional rhythm occurred during superior vena cava (svc) ablation.Sinus map was created, and the ablation was conducted while checking the distance to the sinus node.The point where the ablation was conducted at the time of junction was above the svc line that had been created, so the causal relationship was unknown.Timing was at the svc ablation was conducted for one cycle and the gap on the svc line was ablated.Junctional rhythm occurred when the ablation was conducted for 5 seconds at 30w.The patient left the room as it was.Since the sinus rhythm occurred when isp was administered, the patient was monitored with medication.The patient was hypotensive.Description of health hazard: junctional rhythm, hypotension.Progress (current patient's condition): since the isp administration would result in sinus, the patient is currently being monitored with medication.Physician assessment of the health problem: serious.Extension of hospitalization period: yes.Cf monitoring methods: real time graph; dashboard; vector; visitag.Visitag coloring setting: tag index.Additional filters for visitag: fot.Causal relationship with product: unknown.The physician's opinions on the relationship between the event and the product was -no relationship.There were no abnormalities observed prior to and during use of the product history of medical history/treatment/other diseases currently being treated, etc: on steroid administration.The complaint product(s) will not be returned for analysis.The physician commented that there were no relationship with the product and the event.Intervention provided was that isoproterenol was administrated.Outcome of the adverse event was improved.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

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31016744l and no internal action related to the complaint was found during the review.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).

Manufacturer Narrative

On 6-jul-2023, bwi received additional information regarding the event.The physician commented that there was no relationship with the product and the event.Isoproterenol was administrated.Outcome of the adverse event was improved.Generator information was a smart ablate generator, g4c-1259.Section a has been updated with the following patient information: age (in their 70s, so it's listed as "70"), weight, and gender.The smartablate generator has been added to the concomitant products section.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: 17163873
• MDR Text Key: 317637483
• Report Number: 2029046-2023-01317
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: 31016744L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2023
• 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: CARTO 3 SYSTEM.; OCTARAY CATHETER.; VIZIGO SHEATH.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 50 KG