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

Model Number D134805

Device Problems Device Contamination with Body Fluid (2317); Temperature Problem (3022); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

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.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient born (b)(6) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a cerebrovascular accident requiring prolonged hospitalization.It was reported by the caller that during use of the thermocool® smart touch® sf bi-directional navigation catheter had char on the tip of the catheter.Physician cleaned char from tip, checked irrigation flow and confirmed performance of irrigation and continued use of catheter.The catheter was not replaced and the procedure was continued.After the procedure the patient was slow to wake up, was not moving their right side and was going to have a ct- scan.The patient demonstrates inability to talk and right- side weakness/flaccidity as of last report from physician.The patient required extended hospitalization because of the adverse event, remains in hospital with described symptoms.Physician did not indicate opinion on cause of the adverse event.Per the physician, patient history includes recent ((b)(6) 2021) mitral valve repair 3 months prior with laa closure device (noted on tee to be incomplete closure with residual blood flow in and out of appendage.Patient had perioperative stroke with recovery of symptoms at that time.A smartablate generator used during the case failed to display any temperature on several occasions but physician declined offer to troubleshoot the catheter or change the catheter.Generator parameters were set to power control mode.35-45 watts with nominal temperature cut off settings of 40 celsius.Temperature range during ablations were noted at approximately 20-30 celsius.Patient's activated clotting time (act) was kept between 400-500 throughout case.The carto 3 workstation did not present any errors.The customer¿s reported no temperature displayed is not considered to be mdr reportable the potential that it could cause or contribute to a death or serious injury, or other significant adverse event is remote.

Manufacturer Narrative

On 10-jan-2022, additional information was received clarifying that the b3.Date of event was actually (b)(6) 2021 and not (b)(6) 2021 as previously reported.The field has been updated appropriately.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).

Manufacturer Narrative

On (b)(6)-2022, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a male patient born (b)(6)1984 underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a cerebrovascular accident requiring prolonged hospitalization.It was reported by the caller that during use of the thermocool® smart touch® sf bi-directional navigation catheter had char on the tip of the catheter.Physician cleaned char from tip, checked irrigation flow and confirmed performance of irrigation and continued use of catheter.The catheter was not replaced and the procedure was continued.It was also reported the smartablate generator used during the case failed to display any temperature on several occasions but physician declined offer to troubleshoot the catheter or change the catheter.After the procedure the patient was slow to wake up, was not moving their right side and was going to have a ct- scan.The patient demonstrates inability to talk and right- side weakness/flaccidity as of last report from physician.The patient required extended hospitalization because of the adverse event.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Per the event, several tests were performed.The force, magnetic and temperature features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The catheter passed all specifications.The root cause of the adverse event remains unknown.The root cause of char on tip remains unknown.The evaluation determined that char is a physical phenomenon of rf.Directions for use: increase the irrigation to a high flow rate starting up to 5 seconds before the onset of rf energy delivery and maintain this higher flow rate until 5 seconds after termination of the energy application.For power levels up to 30w, a high flow rate of 8ml/min should be used.For power levels between 31-45wa high flow rate of 15ml/min should be used.Do not use this catheter without irrigation flow.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the reported adverse event and no temperature display issues.Investigation findings: problem due to thrombosis activation (c010604) / investigation conclusions: cause traced to user (d11) / cautery tip (g01002)were selected as related to the reported char.Manufacturer's ref.# (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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13203629
• MDR Text Key: 283485488
• Report Number: 2029046-2022-00063
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2022

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 Expiration Date: 10/15/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30648672L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 01/10/2022; 01/13/2022; 02/07/2022
• Supplement Dates FDA Received: 01/11/2022; 02/01/2022; 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2021
• 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
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male