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

Model Number D134801

Device Problems Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 12/12/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cerebrovascular accident.It was reported that immediately after the end of the procedure, the patient experienced temporary speech disorder.When the catheter was pulled outside of the patient¿s body, it was visually confirmed that an adhesion of something like char was confirmed on the catheter.The procedure was successfully completed before noticing the char issue.Temporary speech disorder is resolved now.The physician noticed the event when the catheter was removed from the patient¿s body.There were no problems with irrigation.Irrigation setting was within the recommended range.The char had been attached to the distal side (medial only).There were no abnormalities observed prior to and during use of the product.The system did not present any error messages and the physician/user did not see any product problem.There were no issues related to temperature and flow on the catheter.The patient experienced cerebral infarction since the procedure was completed.The char was located on the tip of the electrode.Generator parameters includes power control mode, cut off; temperature;42, impedance; unknown, power; 30w.The patient was anticoagulated, but the detail was unknown.Pump information was a m4900208(serial number:(b)(4)).There is no available picture.The issue of char was assessed as not mdr reportable.Char is a physical phenomenon of rf energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.In addition, biosense webster inc.Has reassessed the reportability of char-related events and has determined that these events, which were previously reported as malfunctions, are ¿not reportable.¿ the fda has provided documented concurrence with this.Since the event (cerebrovascular accident) 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

Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30892141l number, 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 24-jan-2023.It was reported that ablation was completed before the event was noted.It was confirmed that the char/thrombus was only on the lasso catheter.Therefore, the h 6.Medical device problem code of device contamination with body fluid (a180103) was removed.Char is not mdr reportable to the us fda.Therefore, no additional 3500a report will be submitted under the lasso catheter.The adverse event was discovered post use of biosense webster products.The physician¿s opinion is unknown regarding the cause of this adverse event.The outcome of the adverse event was improved.The patient did not require extended hospitalization because of the adverse event.Lasso catheter had no failure.The physician¿s name was provided and therefore, section e for initial reporter was 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16217784
• MDR Text Key: 307831104
• Report Number: 2029046-2023-00137
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30892141L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2022
• 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: LASSO NAV 2515,22P SPLITHANDLE; SMARTABLATE PUMP KIT (JAPAN); UNK GENERATOR
• Patient Outcome(s): Life Threatening