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 11/14/2022

Event Type  Injury  

Manufacturer Narrative

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 male patient weighing 335 lbs.Underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade (ct) requiring surgical intervention.It was reported by the bwi representative that during an afib ablation procedure there was a drop in pressure on the "ultrasound system".When investigated, a pericardial effusion (pe) was revealed using the intracardiac echocardiography (ice) ultrasound catheter.To intervene, a pericardiocentesis was used and drained "2800" from the patient however they were able to "give the same amount back to the patient".The patient has since stabilized but the effusion has not gone away.The adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was it was product related as perforation occurred with the ablation catheter.The patient was stable and was walking at the time of the call.Intervention provided was pericardiocentesis and pericardial window.The patient fully recovered (no residual effects).Patient required extended hospitalization because of the adverse event for observation.Relevant tests/laboratory data-hemo 8.6, hematocrit 26.2, rbd 2.99, wbc 8.2, plt 220 (as of 11/21).Other relevant history-chronic af, congestive heart failure, diabetic, high blood pressure, lymphedema, obese, former smoker.Transseptal puncture was performed with a baylis nrg needle.Ablation was performed prior to noting the pe or ct.No evidence of steam pop.The event occurred during ablation.The flow setting for the irrigated catheter used was low flow.Correct catheter settings was 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.Force visualization features used were graph, dashboard, vector, and visitag.Parameters for stability for the visitag module used was range: 2mm; time: 3; fot: 25%; tag size: 3.No additional filter used with the visitag.Color options used prospectively was fti.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Section h3.Has been updated.A manufacturing record evaluation (mre) was performed for the finished device and no internal action related to the complaint was found during the review.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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15975098
• MDR Text Key: 305414237
• Report Number: 2029046-2022-03097
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30898111L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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 GENERATOR SPARE-US; UNK BAYLIS NRG NEEDLE; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 152 KG