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); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.(b)(4).

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.Situation: there was a strange feeling about the change in impedance during energization, and when it was taken out of the body, char was attached.Timing: at posterior wall cautery at 2 hours after use of the catheter.Resolved by replacing the catheter.[stsf char/thrombus].The impedance change was unusual and was noted when the catheter was removed from the body.Resistance did not decrease.Ablation time was greater than 60 seconds (per 1 energization).Ablation time did not exceed 120 seconds (per 1 energization).The total energization time during this procedure was the average 2 hour ·cf did not exceed 40, did not exceed was the irritation setting within the specified range within the specification.The pre-rf time and the post-rf time set was set as pre 1s.Post 3s.The thrombus was attached on the side of the electrode.The set output was 40w.The procedure was completed without patient's consequence.Char /coagulum/thrombus/clot located was located on the side part.No issue related to temperature and flow.But impedance did not decrease.The duration of ablation was used greater than 60 seconds but less than 120 seconds.The average contact force was greater than 25 grams but less than 40 grams.Irrigation setting was within the specified range.The pre-ablation high setting was pre 1s.Post 3s.The duration of ablation was used greater than 60 seconds but less than 120 seconds.Impedance issue is not mdr-reportable.Thrombus/clot is mdr-reportable.

Manufacturer Narrative

On (b)(6) 2023, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.Situation: there was a strange feeling about the change in impedance during energization, and when it was taken out of the body, char was attached.Timing: at posterior wall cautery at 2 hours after use of the catheter.Resolved by replacing the catheter.[stsf char/thrombus].The impedance change was unusual and was noted when the catheter was removed from the body.Resistance did not decrease.Ablation time was greater than 60 seconds (per 1 energization).Ablation time did not exceed 120 seconds (per 1 energization).The total energization time during this procedure was the average 2 hour ·contact force (cf) did not exceed 40, did not exceed was the irritation setting within the specified range ¿within the specification.The pre-rf (radiofrequency) time and the post-rf time set was set as ¿pre 1s.Post 3s ·the thrombus was attached on the side of the electrode.The set output was 40w.The procedure was completed without patient's consequence.Device evaluation details: visual analysis revealed the shaft was bent.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.A cool flow pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 30875363l number, and no internal action was found during the review.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.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: 15988908
• MDR Text Key: 305923012
• Report Number: 2029046-2022-03089
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30875363L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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: CARTO 3 SYSTEM.