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 11/15/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that at the end of the procedure it was noted that the patient had pericardial effusion.This was confirmed via the intracardiac echocardiography (ice) catheter.The patient was stable.The patient had a pericardiocentesis and the reporter is unsure of how much fluid was removed from the patient.The patient did not require surgery for the repair.The reporter has not spoken to the physician after the procedure.The reporter thinks the patient may be staying overnight for observation and they are stable.Additional information was received on the event.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event, is it occurred during the procedure.Medical intervention provided was a pericardiocentesis was performed.The outcome of the adverse event was stable.The patient did require extended hospitalization because of the adverse event.A transseptal puncture was performed.Needle product details: veracross wire.Prior to noting the cardiac tamponade ablation was performed.There was no evidence of a steam pop.It is unknown when this event occurred as the effusion was identified at the end of the case.Force visualization features used were vector, dashboard and visitags.The visitag module was used, the parameters for stability used were standard settings; 3,3,25%3.Additional filter used with the visitag: respiratory.Color options used prospectively: ai.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).During an internal review on 08-dec-2021, noted a correction in the 3500a initial as missing the physician information.Therefore, processed the fields e1.Initial reporter title, e1.Initial reporter first name, e1.Initial reporter last name, e1.Initial reporter email, e3.Initial reporter occupation and e2.Health professional?.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 04-jan-2022.The device evaluation was completed on 11-jan-2022.It was reported that a 68 year old male patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.The patient was stable.The patient did require extended hospitalization because of the adverse event.The device was returned to biosense webster for evaluation.A visual inspection, deflection, magnetic sensor functionality, screening, temperature and impedance, cool flow pump, patency, and ecg tests of the returned device were performed in accordance with bwi procedures.The smart touch bidirectional sf device was visually inspected and it was found in good condition.The magnetic, temperature, and force features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: always zero the contact force reading following insertion into the patient or when moving the catheter from one chamber of the heart to another.Ensure the catheter is not in contact with heart tissue prior to zeroing.Refer to the user manual for your carto®3 system for instructions on how to zero the contact force reading.A manufacturing record evaluation was performed for the finished device 30642994l, and no internal action was found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The lot number was retrieved during the product analysis.Therefore, d4.Lot, d4.Expiration date and h4.Device manufacture date were processed accordingly.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: 12965905
• MDR Text Key: 285329644
• Report Number: 2029046-2021-02143
• 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,Followup,Followup
• Report Date: 01/11/2022

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: 09/20/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30642994L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 12/08/2021; 01/04/2022
• Supplement Dates FDA Received: 12/15/2021; 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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 - VERACROSS WIRE NEEDLE.; SMARTABLATE GENERATOR KIT-US.; UNK_CARTO 3.; UNK_CARTO VIZIGO SHEATH.; UNK_PENTARAY.; UNK_SOUNDSTAR.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male