MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMTCH SF UNID, TC, D; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134701

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 12/21/2022

Event Type  Injury  

Event Description

It was reported that a 49-year-old male patient weighing 120 kg underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident requiring a surgical intervention.It was reported by the bwi representative that there was some impedance increase, but not rapidly.When the catheter was taken out, char was found.The char was cleaned up and the procedure continued; however, the char formation came back.The physician requested a replacement catheter.The catheter was replaced, and the issue continued.They were ablating with a wattage setting from 40 - 50 watts and the case took 5 hours.The formation of char was also happening on the replacement catheter.They requested the return of the catheters for evaluation and requested for the smartablate® generator and pump to come in for evaluation.The pump is also due for preventive maintenance (pm) service.It was also reported that after three hours into the case, the carto® 3 system (v7.2.40.250 ) came up and displayed an error: "the application must restart" and the system reloaded the application.They explained that after the application was reloaded, the option to continue with the study was provided and selected.The case continued and ended successfully.They are requesting a field service engineer (fse) follow up.Dispatch was approved.Additional information was received on 23-dec-2022.It was reported that the patient woke up fine, developed stroke systems late evening that required clot removal by interventionalist.It was also reported that the char was located on the tip only.There are no pictures available.They noticed the impedance increased gradually.The catheter responded normally, no temp warnings, the catheters flushed normally, and we set pump to 15 ml/min to look at flow to catheter to ensure it was cooling properly.Generator parameters were power, temp cut off 40, most burning was at 50-40 watts.The noted temperature, impedance, and power were burning temp of 30, imp upper 90¿s-100¿s then gradual rise, power 50-40 w.Pt act was close to 350.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.Most ablations were less than 60 sec.Most ablations were less than 25 grams, there were a few ablations that were 40g.Irrigation rate settings were correct.The pre-ablation high setting was pre rf cooling is 2.Carto visitag module settings were set to recommended settings.Color options used prospectively was impedance.The impedance increase was slow and gradual, no cut off.The user was able to stop the ablation using the ¿stop¿ button (generator or remote).There was no failure on the smartablate generator, nor on the smartablate pump.Additional information was received on 29-dec-2022.It was reported that physician¿s opinion on the cause of this adverse event was that it was procedure/patient condition related.Intervention provided was that the patient was taken for removal of clot.The patient fully recovered.Patient did not require extended hospitalization because of the adverse event.Generator information was a stockert gmbh; model smartablate; and serial g4c-0250.The issue with char was assessed as not mdr reportable.Char is a physical phenomenon of radiofrequency (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.The issue with high impedance was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.Since the event (cva) 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

The biosense webster, inc.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.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.Biosense webster manufacturer's reference number pc-001263983 has two reports: (1) mfr # 2029046-2023-00116 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2023-00115 for product code d134701 (thermocool® smart touch® sf uni-directional navigation catheter).

Manufacturer Narrative

The device evaluation was completed on 19-jan-2023.It was reported that a 49-year-old male patient weighing 120 kg underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident requiring a surgical intervention.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed char on the tip of the device; small char residues were observed on the tip.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested, and no issues were observed.In addition, the product was deflecting correctly, however the irrigation was out of specifications.A manufacturing record evaluation was performed for the finished device 30907601l number, and no internal action related to the complaint was found during the review.The impedance issue reported by the customer was not confirmed however, char was confirmed.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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).

• Brand Name: THMCL SMTCH SF UNID, TC, D
• 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: 16199997
• MDR Text Key: 307657788
• Report Number: 2029046-2023-00115
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30907601L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; THMCL SMTCH SF BID, TC, F-J
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 120 KG