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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 08/18/2023

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.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).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac perforation requiring a pericardiocentesis.During right pulmonary vein (rpv) isolation with thermocool® smart touch® sf bi-directional navigation catheter, after 22 ablations (roof site), blood pressure went down below 100 and perforation was noticed.Timing was approximately 1 hour after catheter use, during rpv isolation.Atrial septal puncture was performed with rf needle.Ablation was performed before cardiac tamponade was identified.Steam pop was not observed.Irrigation catheter¿s flow rate setting was 15 ml for high and 8 ml for low.Description of health hazard was cardiac tamponade.Physician assessment of the health problem was non-serious (moderate/minor).Cf monitoring methods was real time graph; dashboard; vector; visitag.Coloring setting of visitag was tag index.Causal relationship with product was unknown.There were no abnormalities observed prior to and during use of the product.Additional information was received on 23-aug-2023.Progress (current patient's condition) was drainage was performed during the procedure.The procedure was interrupted during rpv isolation (24 ablations performed).Lpv isolation was not performed.The patient's condition is currently unknown.Additional information was received on 01-sep-2023.Physician¿s opinion on the cause of this adverse event was the patient condition.The left atrium was thin and small.Outcome of the adverse event was improved.Generator information was a model: m4900207, serial number: (b)(6).Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Additional filter used with the visitag was ablation index only.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 26-sep-2023.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).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac perforation requiring a pericardiocentesis.The investigation was completed on 27-oct-2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed and during the analysis, hi force and a negative force vector were observed in one of the curves of the device.For this type of failure mode, a manufacturing investigation was performed and it was determined that the observed issue is related to the manufacturing process during the internal wire assembly.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The adverse event could be related to the force issue found during the product investigation.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.An internal corrective action has been opened to address this issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17741271
• MDR Text Key: 323359750
• Report Number: 2029046-2023-02064
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2023

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 Catalogue Number: D134805
• Device Lot Number: 31085166L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 09/26/2023; 10/27/2023
• Supplement Dates FDA Received: 10/02/2023; 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2023
• 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: SMARTABLATE GEN. KIT (JAPAN); UNK PUMP; UNK_CARTO 3; UNK_RF NEEDLE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male