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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation on 01/29/2021.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 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 (b)(6) female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and developed thrombosis (thromboembolism) requiring no interventions.During the procedure while using the stsf catheter, a clot was dislodged from the tip of the catheter when it was removed from the left atrium (la).This was verified by the ultrasound catheter.They noted the clot was freely floating in the la via the ultrasound.They then lost sight of the clot in the la.When they turned the catheter, they saw what they believed to be the clot in the ascending aorta.The patient was stable.They observed the clot for 30 minutes and it slowly dissipated, and they lost sight of the clot again.The caller stated that they did go back in with a pentaray catheter and did flutter mapping but decided not to ablate due to the clot.The patient then went for a computerized tomography (ct) angiogram of the head and neck to assess for clot.No large vessel occlusion was found, and the patient did not need any further intervention.The report of the ct angiogram came back saying there were no large vessel occlusions and the patient is stable.The patient stayed one night in the hospital for observation.The patient had fully recovered.The patient did not exhibit any neurological symptoms since the issue was completed.The physician understands and verbalized that the char buildup was likely a result of off label use of the product (irrigating an stsf catheter at only 2ml/min during ablation).There were no issues related to flow or temperature.The catheter was used in power control mode at 40w, with a temp cut-off of 40 degrees c, a pre-rf irrigation time of 2 seconds, and a post irrigation time of 2 seconds.The catheter was also occasionally used in an off-label fashion: irrigating only at 2ml/min, power control mode at 35w, with a temp cutoff of 95 degrees c.The temperatures during ablation were below the cut-off for all ablation sessions.The impedance ranged from 130-180 ohms with two grounding pads.The power was either 40w (when using normal, irrigated settings for the stsf catheter) or 35w (when ablating off label at 35w and 2ml/min flow).The activated clotting time (act) practice of the physician is to maintain 350 act, and this was maintained throughout the case.The duration of ablation used was never greater than 60 seconds.The average contact force was occasionally greater than 40 g, but not for extended periods of time.The contact force was routinely between 25 g and 40 g.Most of the ablation were done with a power up to 30 w, high flow rate of 8 ml/min; 31 w or greater, high flow rate of 15 ml/min.There were a few lesions on the posterior wall of the la, in which the physician used a constant 2ml/min flow, power control mode, 35w, with a temp cutoff of 95 deg c.The pre and post ablation flow setting was 2 seconds.Heparinized normal saline was used throughout the case.Visitag module was used with the following parameters: repiration gating on, stability range 3mm, stability time 3 sec, force overtime 25% at 3g, tag size 2mm.Impedance was used as coloring option.

Manufacturer Narrative

H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.H6.Component code of "appropriate term/code not available" represents "char on electrodes" it was reported that a 70-year-old female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and developed thrombosis (thromboembolism) requiring no interventions.During the procedure while using the stsf catheter, a clot was dislodged from the tip of the catheter when it was removed from the left atrium (la).This was verified by the ultrasound catheter.They noted the clot was freely floating in the la via the ultrasound.They then lost sight of the clot in the la.When they turned the catheter, they saw what they believed to be the clot in the ascending aorta.The patient was stable.They observed the clot for 30 minutes and it slowly dissipated, and they lost sight of the clot again.The caller stated that they did go back in with a pentaray catheter and did flutter mapping but decided not to ablate due to the clot.The patient then went for a computerized tomography (ct) angiogram of the head and neck to assess for clot.No large vessel occlusion was found, and the patient did not need any further intervention.The report of the ct angiogram came back saying there were no large vessel occlusions and the patient is stable.The patient stayed one night in the hospital for observation.The patient had fully recovered.The patient did not exhibit any neurological symptoms since the issue was completed.The physician understands and verbalized that the char buildup was likely a result of off label use of the product (irrigating an stsf catheter at only 2ml/min during ablation).There were no issues related to flow or temperature.The investigational analysis has been completed on (b)(6) 2021.A video showing carto display was received for analysis, evidence of char cannot be found, the video does not provide sufficient information related to the reported event and therefore no result can be obtained from it.Customer complaint cannot be confirmed.The product analysis was performed as appropriate in order to find root cause of the complaint.The device was visually inspected, and it was found in good condition.The char was observed on the tip when the catheter was received at the decontamination lab.The device was tested and the force, magnetic, electrical and temperature conditions were found to be all within specifications.There were no issues observed.Additionally, flow, patency and deflection tests were performed, and they were found to be within specifications.The catheter was irrigating correctly, and no irrigation or deflection issues were observed.A manufacturing record evaluation was performed for the finished device 30450953m number, and no internal action related to the reported complaint was found during the review.The device was found in good condition; however, since the char was observed on the tip of the catheter during the decontamination process, the root cause of the adverse event remains unknown.The physician understands and verbalized that the char buildup was likely a result of off label use of the product (irrigating an stsf catheter at only 2ml/min during ablation).Char is a physical phenomenon of radiofrequency.It can be the normal result of the ablation process.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11276118
• MDR Text Key: 230222694
• Report Number: 2029046-2021-00129
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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: 10/11/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30450953M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR SPARE-US; SMARTABLATE PUMP SPARE-US; UNKNOWN BRAND SHEATH; UNKNOWN BRAND ULTRASOUND CATHETER; UNK_PENTARAY
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR