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

Model Number D134805

Device Problems Complete Blockage (1094); Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317); High Readings (2459)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus / clot issue occurred.Initially it was reported that there was char present on the tip of ablation catheter (thermocool® smart touch® sf bi-directional navigation catheter).There was no irrigation on the direction of the tip.No patient consequences known at this time.It was not known if the surgery was delayed due to the reported event.It was unknown if the procedure was completed successfully.It was not known if there was any medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision).Additional information was received on (b)(6)2023.The char was located on the tip electrode.The system presented with an error message or the physician saw a product problem as the impedance cut off of the smartablate generator stopped ablation.There was an issue related to the temperature and flow on the catheter.Flow was abnormal.The generator parameters were set as power control mode, 40 degrees celsius cut off for temperature and no cut off for power.The noted temperature, impedance, and power were average impedance 150 ohms, power 50 watts and average temperature 24 degrees celsius.The patient was anticoagulated.The act was set as > 300.This maintained throughout the case.Picture was provided.The physician considered that the char was excessive (based on their clinical experience).The physician considered the amount of char observed caused a potential risk to this patient.The correct catheter settings selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.Only 2 ablations sessions were > 60 seconds (74 seconds and 94 seconds).Average contact force was under 40 grams for all ablation sessions.Less than 10 ablations sessions were between 25 and 40 grams.The irrigation rate was not used outside of those prescribed, except for ablation sessions in coronary sinus: 15ml/min flow was apply at 25 watts.The pre-ablation rf time: 2 second high flow 8-15ml/min.Heparinized normal saline was used as the irrigation fluid.No other type of saline was used.The carto visitag module was used (tag size 2mm.Respiration adjustment checked, stability range 3mm, stability time 3 sec, force over time 25% 3g).The color options used was tag index.This event was originally considered non-reportable, however, bwi became aware of additional information that the char was excessive and created a risk to the patient on (b)(6)2023 and have reassessed the event as mdr reportable for a thrombus/clot issue.

Manufacturer Narrative

The picture investigation was completed on 16-jun-2023.The pictures were received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, char (thrombus/clot) was observed on tip.The char (thrombus/clot) observed on the tip of the device could be related to the irrigation issue reported by the customer; however, this cannot be conclusively determined.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.Char is a physical phenomenon of radiofrequency; it can be the usual result of the ablation process; however, the instructions for use contain the following instruction: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(6) during an internal review noted some corrections in the 3500a initial: -on 17-aug-2023, noted a correction as should have included under h6.Medical device problem code the code of ¿coagulation in device or device ingredient (a030202)¿.-on 21-aug-2023 noted a correction as should have included under h6.Investigation findings the code of ¿contamination of environment by device (c1503)¿.Therefore, updated these fields.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-001361474 on 10-oct-2023, the picture investigation was reopened to clarify/correct the investigation findings which resulted in the following changes/correction.The pictures were received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, char was observed on tip.The char observed on the tip of the device could be related to the irrigation issue reported by the customer; however, this cannot be conclusively determined.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.Char is a physical phenomenon of radiofrequency; it can be the usual result of the ablation process; however, the instructions for use contain the following instruction: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Removed from h6.Investigation findings "problem due to thrombosis activation (c010604).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that there was char present on the tip of ablation catheter (thermocool® smart touch® sf bi-directional navigation catheter).There was no irrigation on the direction of the tip.No patient consequences known at this time.It was unknown if the procedure was completed successfully.Additional information was received.The char was located on the tip electrode.The physician considered that the char was excessive (based on their clinical experience).The physician considered the amount of char observed caused a potential risk to this patient.The bwi product analysis lab received the device for evaluation on 12-mar-2024.The device evaluation was completed on 28-mar-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, flow pump, and temperature and impedance tests of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed.Temperature and irrigation test were performed, and no issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues 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 evaluation determined that char is a physical phenomenon of radio frequency, it can be the normal result of the ablation process.The instructions for use contain the following guideline: monitoring the temperature from the electrode during the application of radio frequency (rf) current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and increased risk for collateral damage.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 09-apr-2024, noted a correction to the 3500a initial as under h6.Medical device problem code should have included "high readings (a090807)".Therefore, on 18-apr-2024, the picture investigation was reopened to clarify/correct the investigation findings which resulted in the following changes/correction.A picture was received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, char was observed on tip.The char observed on the tip of the device could be related to the irrigation and impedance issues reported by the customer; however, this cannot be conclusively determined.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.Char is a physical phenomenon of radiofrequency; it can be the usual result of the ablation process; however, the instructions for use contain the following instruction: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained the customer complaint was confirmed based on the picture received.

• 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: 17218743
• MDR Text Key: 318282429
• Report Number: 2029046-2023-01406
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31033886L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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: SMARTABLATE GENERATOR KIT-WW; UNKNOWN BRAND PUMP; UNK_CARTO 3