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

Catalog Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

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 issue occurred.Thrombus adherence.Timing occurred when the thermocool® smart touch® sf bi-directional navigation catheter was removed from the patient's body after pvi.The issue was noticed when the catheter was removed from the patient¿s body.No problem related to temperature, resistance nor irrigation.Ablation did not exceed 60 seconds nor did it exceed 120 seconds.The total ablation time for the procedure was 50 minutes.The average contact force (cf) value did not exceed 25 grams nor did it exceed 40 grams.The irrigation setting was within the specified range.The time was set respectively to pre 3 sec and post 3 sec.The power setting was set to 30-40 watts.The thrombus attached to the distal side of the electrode.Additional information was received.The thrombus was located on the tip electrode.The system did not present any error messages nor did the physician/user see any product problem.No issues related to temperature nor flow on the catheter.The patient did not exhibit any neurological symptoms since the procedure was completed.The thrombus issue was assessed as mdr reportable.

Manufacturer Narrative

Additional information was received on 12-sep-2023.The generator was set to power control mode and temperature cut off at 40.No abnormal noted temperature, impedance, and power values were found.The patient was anticoagulated.The act practice of the physician is above 300 seconds.The patient has not exhibited any neurological symptoms since the procedure was completed.Also provided the generator and pump information.Therefore, d10.Concomitant medical products and therapy dates was processed.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 05-oct-2023, noted a correction to the 3500a initial.The h6.Medical device problem code was processed as device contamination with body fluid (a180103) and it should have been coagulation in device or device ingredient (a030202).Therefore, processed this field.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 17-oct-2023.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.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

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.The device evaluation was completed on 30-oct-2023.The device was returned to biosense webster for evaluation.A visual inspection, cool flow pump, temperature, and impedance test of the returned device were performed in accordance with bwi procedures.The device was visually inspected, and thrombus/clot attached on the electrode of the device's tip was observed.The temperature test was performed, and no issues were observed.A cool flow pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.No malfunctions were observed during the device analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: 17654103
• MDR Text Key: 322325152
• Report Number: 2029046-2023-01942
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31060106L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2023
• 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 GEN. KIT (JAPAN); SMARTABLATE PUMP KIT (JAPAN)