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

Model Number D134805

Device Problem 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 thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ 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 carto vizigo¿ 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 carto vizigo¿ 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 thermocool® smart touch® sf 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 thermocool® smart touch® sf bi-directional navigation catheter was correctly selected.The reporter confirmed that the generator had not rebooted.The issue was easily resolved by reselected thermocool® smart touch® sf bi-directional navigation catheter settings and the case continued (this occurred prior to the patient event).Additional information was later received indicated carto vizigo¿ 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 the scraping of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium along the septum in preparation for the tsp, or 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 thermocool® smart touch® sf bi-directional navigation catheter settings.Transseptal procedure was used with brk needle.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 # 2029046-2021-02198 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).Importer report number # (b)(4) product code m490007 (smartablate¿ system rf generator (us).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13015809
• MDR Text Key: 285325011
• Report Number: 2029046-2021-02198
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; BRK NEEDLE; CARTO 3 SYSTEM; MERIT SHEATH (NON-BWI); SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female