MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATETM SYSTEM RF GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	M490007
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the caller, clinical account specialist, that the physician informed the clinical account specialist today that the patient had a stroke post atrial fibrillation ablation procedure.The caller stated that during the procedure the health care professional staff member set the settings on the smartablate generator incorrectly to a 4mm catheter.The caller stated that there was char on the catheter tip and there were 4 steam pops during the procedure.The caller stated that about halfway through the procedure it was noted that the settings on the smartablate generator were set incorrectly.The caller stated that there was no indication immediately post procedure that the patient had suffered from a stroke.The caller stated that the patient was stable during the procedure and when they left the lab.The caller also stated that the ep physician requested a neuro team consult immediately post procedure as a preventative measure, before the patient left the ep lab.The caller stated that the neuro physician advised the ep physician to monitor the patient for any stroke like signs or symptoms, at that time.The caller stated that the patient lost part of their vision, which is what potentially prompted the stroke team to initiate the stroke response process.The caller stated that the physician assumes that the char moved from outside of the heart and made its way to the brain.The patient remained stable and as far as the clinical account specialist knows they are still in stable condition.As of this morning.Unk lot number: ablation catheter was discarded, smartablate generator: (b)(6), ep medtech products: decanav, octaray, vizigo, & soundstar catheters.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation ablation, and the patient experienced a stroke and required prolonged hospitalization.Device analysis details: remote support confirmed the unit was performing as intended, therefore no failure was found with the system.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of johnson & johnson medtech's quality 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: SMARTABLATETM SYSTEM RF GENERATOR
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 31; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 21050469
• Report Number: 2029046-2024-50007
• Device Sequence Number: 18425438
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M490007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2024
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THMCL SMTCH SF BID, TC, D-F.; UNK DECANAV.; UNK TRANSSEPTAL NEEDLE.; UNK_CARTO VIZIGO SHEATH.; UNK_OCTARAY NAV.; UNK_SOUNDSTAR.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Sex: Unknown