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 Problem Rupture (2208)

Event Date 12/27/2021

Event Type  Injury  

Manufacturer Narrative

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.A manufacturing record evaluation was performed for the finished device 30656686l number, and no internal action related to the complaint was found during the review.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.Post procedure by more than a month the patient suffered focal inflammation of the valve which required mechanical valve replacement.There was no error message during the procedure and the physician also mentioned that there were no problems with the procedure.However, after more than one-month, focal inflammation developed in the mechanical valve.Surgical intervention performed was a mechanical valve replacement.The physician mentioned that there were no problems with the valve replacement.The patient's course was good.The physician¿s opinion on the cause of the adverse event was that it was not related with the procedure and the biosense webster inc.(bwi) product.The physician stated that perivalvular ablation was not performed.The physician also commented that the ablation procedure was unlikely to be the cause because it was performed with care.The patient outcome of the adverse event was improved with mechanical valve placement.The patient did not require extended hospitalization because of the adverse event.The procedure was a re-valvuloplasty.During the ablation procedure, contact force was monitored by real time graph, dashboard, vector and visitag with the color setting of visitag was tag index.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

Additional information was received on 4-apr-2022, the generator used in the case was a smartablate with serial number unknown.Therefore, the concomitant product section was updated.The physician¿s name was also provided.Therefore, the e1.Initial reporter title, e1.Initial reporter first name, and e1.Initial reporter last name were updated.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13897744
• MDR Text Key: 289507648
• Report Number: 2029046-2022-00627
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30656686L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2.; UNK_CARTO 3.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male