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 Cardiac Tamponade (2226)

Event Date 11/19/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) female patient underwent a afib paroxysmal ablation procedure with a (b)(6) bi-directional navigation catheter and a (b)(6) system rf generator (us) and the patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the patient suffered a pericardial effusion during an afib procedure.The reporter stated that the transseptal procedure was difficult with the (b)(6) 8.5f bi-directional guiding sheath medium that was originally in use.It was reported the sheath/dilator may have been "scraping" along the septum/fossa ovalis.The physician was unable to perform the transseptal puncture with the (b)(6) 8.5f bi-directional guiding sheath medium so they switched to a merit sheath to complete it.The procedure was continued and after completing the right pulmonary vein wide-area circumferential ablation (waca), and half of the left waca, a drop in the patient's blood pressure was noted.The intracardiac echo (ice) catheter was used to confirm the growing effusion.The physician completed the left waca before performing a pericardiocentesis to treat the growing effusion.An unknown amount of fluid was removed.The patient's pressure stabilized, and they were moved to an inpatient room after completion.The physician was uncertain what may have caused the effusion, either difficult transseptal procedure or during radiofrequency (rf) delivery.The physician did not indicate if they believed bwi products contributed to the event.It was also reported that after the 3rd or 4th ablation with the (b)(6) bi-directional navigation catheter and visitags appearing normally on the carto 3 map, the visitags all of a sudden appeared gray.They ensured that surpoint settings were correct and that the catheter was out of the sheath tip properly.They then discovered that the smartablate generator was set for 4mm catheter and was delivering zero watts.The staff and caller were uncertain, but a smartablate generator button could have been accidentally pressed.The reporter was certain that at the beginning of the case the (b)(6) bi-directional navigation catheter was correctly selected.The reporter confirmed that the generator had not rebooted.The issue was easily resolved by reselected (b)(6) bi-directional navigation catheter settings and the case continued (this occurred prior to the patient event).Additional information was later received indicated (b)(6) 8.5f bi-directional guiding sheath medium was used and pericardial effusion was observed after transseptal puncture (tsp), after right waca was completed, and during left waca.It was not noted at which point the pericardial effusion started.Pericardiocentesis was performed.Patient was admitted for a longer than anticipated stay as a result of the adverse event, and their condition improved.The physician¿s thoughts on the cause was either (a) the scraping of the (b)(6) 8.5f bi-directional guiding sheath medium along the septum in preparation for the tsp, or (b) the trans septal puncture itself.No tissue injury was seen on the septum itself.No evidence of steam pop was seen.The smartablate pump was switching from low to high flow during ablation.No errors were shown during procedure.Regarding contact force ablation catheter, dashboard, graph, vector, and visitags were all utilized.Prospectively, tag index was used.3mm visitags, visitag settings were range: 3mm, time: 3ms, and force over time (fot) of 25% over 3g.Using ¿staf¿ and on the correct smartablate settings and after the first 4-5 successful ablations, visitags (with surpoint values assigned), smartablate apparently reset settings back to 4mm, resulting in three separate ablations without surpoint values (grey tags), likely no irrigation during those three ablation points.Tech noticed the problem and once again selected the appropriate (b)(6) bi-directional navigation catheter settings.Transseptal procedure was used with brk needle.

Manufacturer Narrative

The hardware investigation has begun but it has not been 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.Biosense webster inc.Reference number (b)(4 )has two reports: (1) manufacture report number # (b)(4) for product code (b)(4) ((b)(6) bi-directional navigation catheter).(2) importer report number # (b)(4), product code (b)(4) ((b)(6) system rf generator (us)).

Manufacturer Narrative

On 16-jan-2022, additional information was received indicating the serial number for the smartablate generator kit-us was g4c-2069 and not g4c-0255 as previously reported.As such, field d4.Serial has been updated.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 63 year-old female patient underwent a afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient suffered cardiac tamponade requiring pericardiocentesis.The physician was uncertain what may have caused the effusion, either difficult transseptal procedure or during radiofrequency (rf) delivery.The physician did not indicate if they believed bwi products contributed to the event.Using ¿staf¿ and on the correct smartablate settings and after the first 4-5 successful ablations, visitags (with surpoint values assigned), smartablate apparently reset settings back to 4mm, resulting in three separate ablations without surpoint values (grey tags), likely no irrigation during those three ablation points.Tech noticed the problem and once again selected the appropriate thermocool® smart touch® sf bi-directional navigation catheter settings.Device evaluation details: the device investigation has been completed.A biosense webster inc (bwi) field service engineering (fse) provided support for the unit and no failures related to the reported event was found.A device history record evaluation was performed for the finished unit and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• 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: 13015810
• MDR Text Key: 286257124
• Report Number: 2029046-2021-50013
• 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,Followup,Followup
• Report Date: 11/24/2021,03/09/2022

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 Model Number: M490007
• Device Catalogue Number: M490007
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2022
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 01/16/2022; 01/16/2022
• Supplement Dates FDA Received: 02/07/2022; 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC; BRK NEEDLE; CARTO 3 SYSTEM; MERIT SHEATH (NON-BWI); SMARTABLATE PUMP KIT-US; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female