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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2021.The analysis has begun but is not 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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that patient underwent an atrial fibrillation (afib) ablation procedure with a (b)(6) bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that during the procedure, a pericardial effusion was noticed.The pericardial effusion was discovered when the patient blood pressure dropped.The pericardial effusion was confirmed by intracardiac echocardiography (ice) with a soundstar eco catheter.The medical intervention provided was a pericardiocentesis and 970 cc of fluid was removed.The patient was reported to be in stable condition.It is unknown what caused the pericardial effusion.There was no high force during ablation.

Manufacturer Narrative

It was reported that patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.The device evaluation was completed on 15-dec-2021.The device was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the device.Visual analysis of the returned product revealed that no damage or anomalies were observed on the smart touch sf (bidirectional).Per the event, several tests were performed.The magnetic, 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 batch number, and no internal actions were identified.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 11-jan-2022.The patient is a 65 year-old-male patient (194 lbs.) this event was discovered during use of biosense webster, inc.Products.The physician thought maybe it was using too high power on the posterior wall (45 w for <10 seconds).Initially, a pericardiocentesis was performed.Later on, the patient coded, and surgical intervention was performed.No perforations were found during surgery, but the ablation sites were oozing blood.When the reporter last spoke with the physician yesterday, he had checked on the patient and the patient was improving.The patient did require extended hospitalization as they had to stay longer to be monitored after surgery.Previous history of stroke.A transseptal puncture was performed.Needle details: abbott brk needle.Prior to noting cardiac tamponade, ablation was performed.There was no evidence of steam pop.This event occurred during ablation phase.An irrigated catheter was used in the event, the flow setting was standard flow settings for stsf.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Graph, dashboard, vector, and visitag force visualization features were all used.The visitag module was used, the parameters for stability used were recommended surpoint settings (3, 3, 25%, 3) and tag size 3 mm.Additional filter used with the visitag: respiration adjustment was checked/selected.Color options used prospectively tag index.As for updates on the patient condition, they believe that they are now recovered.Therefore, updated a.Patient information section, b7.Medical history/preexisting condition field, b2.Is hospitalization initial/prolonged field, e.Initial reporter section, d10.Concomitant medical products and therapy dates section and h6.Health effect - impact code field.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® 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13014697
• MDR Text Key: 286256295
• Report Number: 2029046-2021-02196
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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,Followup,Followup
• Report Date: 01/20/2022

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 Expiration Date: 09/09/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30638247L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 12/15/2021
• Supplement Dates FDA Received: 01/09/2022; 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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: NON BWI-ABBOTT BRK NEEDLE.; SMARTABLATE GENERATOR KIT-US.; UNKNOWN BRAND PUMP.; UNK_CARTO 3.; UNK_SOUNDSTAR ECO.
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 88 KG