MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE¿ SYSTEM RF GENERATOR (US); CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M490007

Device Problems Activation, Positioning or Separation Problem (2906); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 03/16/2022

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number (b)(4) has two reports: manufacture report number # 2029046-2022-00779 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).Importer report number # 2029046-2022-50006 product code m490007 (smartablate¿ system rf generator (us)).

Event Description

It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and smartablate¿ system rf generator (us) and the patient suffered a cerebrovascular accident requiring prolonged hospitalization.During the case a thermocool® smart touch® sf bi-directional navigation catheter was in use for ablation but the incorrect settings for the catheter were set on the smartablate® generator.The catheter was set as a 4mm catheter and the cooling was always in low flow.The physician asks for 50watts rf delivery and an issue with impedance began to display after some time.After realizing the wrong setting were being used, the bwi representative suggested for the catheter be pulled out and inspected.The physician pulled the catheter out and found char on the catheter.The char was cleaned up, but the physician requested a new catheter to continue with the case.Catheter settings selected on the generator were changed by the staff to the watts the doctor prefers on a 4 mm setting.Post-ablation around 45 mins after the procedure the patient was in stable condition.The bwi representative was notified that the patient had a stroke after about 1hr 30mins after the last ablation while in recovery.The patient was in stable condition but unable to talk at the time.The physician¿s opinion on the cause of this adverse event is unknown.Intervention provided is unknown since the issue occurred in the recovery.The patient required extended hospitalization because of the adverse event for additional care needs.The outcome of the adverse event was stable and unchanged as of on (b)(6) 2022.No malfunction was reported with the smartablate¿ system rf generator (us) and servicing for this equipment is not needed.There was evidence of char during the procedure but no evidence of blood thrombus / clot during the procedure.The pump was not switching from low to high flow during ablation because of the setting for 4mm catheter.Additional information received indicated the was char was found on the of the tip electrode.The system presented a one-time impedance error and the staff cleared it.The impedance cut-off did exceed one time and the system did stop ablation as it was supposed to.The system did not continue to ablate above impedance cut-off value.Generator parameters used were power control and standard cut offs.The power was set at 50w.The impedance started at 140's and would slowly climb.They are unsure of the temperature, but there we no temperature issues and everyone was unaware of the flow issue.The patient was anticoagulated with heparin, act was maintained through the procedure, and it is believed that protamine was given at the end of the procedure.

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR (US)
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 14080771
• MDR Text Key: 289087526
• Report Number: 2029046-2022-50006
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2022,04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M490007
• 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: 03/16/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F; UNKNOWN PUMP
• Patient Outcome(s): Hospitalization; Life Threatening