MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 02/13/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported a patient underwent a cardiac ablation procedure which included the use of a thermocool smarttouch sf ablation catheter.Patient experienced diaphragmatic paralysis and procedure was cancelled.Initial report: ablation was conducted at the proximal portion of the diaphragmatic nerve by setting power 30 w.The ablation time was about 5 to 15 seconds.After four points' ablations, the presence or absence of the twitching phenomenon was confirmed by stsf pacing, but it could not be confirmed at the upstream side of the nerve from the ablation site, and it was confirmed at the downstream side of the nerve.Therefore, the physician judged that there was a possibility of diaphragmatic nerve paralysis.Timing when complaints occurred about 200 minutes after the start of the procedure.To complete the procedure: after judging that there was the possibility of diaphragmatic nerve paralysis, another procedure was performed as a waiting for 30 minutes.The presence or absence of the twitching phenomenon was confirmed again by stsf pacing, but the same phenomenon as before waiting was confirmed.The physician confirmed that the target tachycardia was not induced, and the procedure was terminated.Adverse event: diaphragmatic nerve paralysis.This time, the twitching site was confirmed just before the ablation of the target site.Since some tags were attached to the position of the phrenic nerve, the presence of the nerve was predicted to some extent, but the physician noticed that the ablation was conducted at the position overlapping the position of the phrenic nerve at the time of the ablation and stopped ablation.The physician considered that the diaphragmatic nerve was affected because he noticed the above state a little late.The physician's opinions on the relationship between the event and the product (comments): there is no comment particularly on the relationship with the product.No abnormalities observed prior to use of the product.No abnormalities observed during use of the product.[relevant medical history]: pvi (pulmonary vein isolation) was performed for af procedure approximately one year ago.Pacemaker leads was implanted both atrial and ventricular sides of the body.The patient has had mitral valve replacement surgery in the past, and the mitral valve is currently a mechanical valve.Additional information received reports the following: physician¿s opinion on the cause of this adverse event -procedure.Since some tags were attached to the position of the phrenic nerve, the presence of the phrenic nerve was predicted to some extent, but the physician noticed that the ablation was conducted at the position overlapping the position of the phrenic nerve at the time of the ablation and stopped ablation.The physician considered that the phrenic nerve was affected because he noticed the above state a little late.Further additional information received reports no surgical procedure was performed.No additional procedures were performed.The presence or absence of nerve paralysis was checked again after setting a waiting time of about 20 minutes after ablation.The diaphragmatic nerve paralysis has not resolved.Prolongation of hospitalization has not been confirmed.No relevant tests/laboratory data.Smartablate generate was used but serial number is unknown.For irrigation setting, high was set at 8 ml/min for under 30w, 15 ml/min for above 31w, low was set at 2ml/min, pre rf was set for 1 second, post rf was set for 5 seconds, and the power at ablation was set at 30 w.Since the event 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

On 3-apr-2023, the product investigation was completed.It was reported a patient underwent a cardiac ablation procedure which included the use of a thermocool smarttouch sf ablation catheter.Patient experienced diaphragmatic paralysis and procedure was cancelled.Initial report: ablation was conducted at the proximal portion of the diaphragmatic nerve by setting power 30 w.The ablation time was about 5 to 15 seconds.After four points' ablations, the presence or absence of the twitching phenomenon was confirmed by stsf pacing, but it could not be confirmed at the upstream side of the nerve from the ablation site, and it was confirmed at the downstream side of the nerve.Therefore, the physician judged that there was a possibility of diaphragmatic nerve paralysis.Timing when complaints occurred about 200 minutes after the start of the procedure.To complete the procedure: after judging that there was the possibility of diaphragmatic nerve paralysis, another procedure was performed as a waiting for 30 minutes.The presence or absence of the twitching phenomenon was confirmed again by stsf pacing, but the same phenomenon as before waiting was confirmed.The physician confirmed that the target tachycardia was not induced, and the procedure was terminated.Adverse event: diaphragmatic nerve paralysis.This time, the twitching site was confirmed just before the ablation of the target site.Since some tags were attached to the position of the phrenic nerve, the presence of the nerve was predicted to some extent, but the physician noticed that the ablation was conducted at the position overlapping the position of the phrenic nerve at the time of the ablation and stopped ablation.The physician considered that the diaphragmatic nerve was affected because he noticed the above state a little late.The physician's opinions on the relationship between the event and the product (comments): there is no comment particularly on the relationship with the product.No abnormalities observed prior to use of the product.No abnormalities observed during use of the product.Device evaluation details: visual analysis revealed no damage or anomalies on the device.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 and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device number lot: 30922863l and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The physician's opinions on the relationship between the event and the product (comments): the adverse event due to the procedure.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: THERMOCOOL SMARTTOUCH SF ABLATION 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: 16543584
• MDR Text Key: 311291842
• Report Number: 2029046-2023-00529
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30922863L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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: PENTARAY NAV.; SMARTABLATE GENERATOR.
• Patient Outcome(s): Life Threatening
• Patient Sex: Female