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

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/07/2024

Event Type  Injury  

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.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.Note: field d4 catalog should be unk_smart touch bidirectional sf.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number: (b)(4) has two reports: (1) mfr#: for product thermocool® smart touch® sf bi-directional navigation catheter.(2) mfr#: 2029046-2024-01113 for product lassostar nav circular mapping catheter.

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a lassostar nav circular mapping catheter and the patient experienced pericardial effusion that required pericardiocentesis.After the cryo portion of the case, while mapping with the lassostar nav circular mapping catheter on the posterior wall and roof of the left atrium, the anesthesiologist reported that the patient had low blood pressure.Intracardiac echo (ice) revealed an effusion.A pericardiocentesis was performed, removing 700 cc of fluid.The patient was stable at the time of the call.The physician used a bwi ablation catheter to ablate the cavotricuspid ishmus (cti) line in the right atrium (ra), and was about to ablate on the la roof when the low blood pressure was reported.The physician stated that they believed the issue occurred while mapping the roof with the lassostar catheter.The physician¿s opinion on the cause of this adverse event that it was bwi product malfunction.Doctor claimed he thinks that the lassostar nav circular mapping catheter poked through the roof.But it is really unknown as numerous events took place throughout the procedure that could have caused it.Ablation was performed prior to noting the pericardial effusion, but only in the ra.No evidence of steam pop.No error messages observed on biosense webster equipment during the procedure.Patient fully recovered but stayed overnight at the hospital.Since the location of the pericardial effusion is unknown and it cannot be determined whether the mapping or the ablation catheter is the most suspected device, the event will be conservatively reported on both.

• 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: 19029717
• MDR Text Key: 339207682
• Report Number: 2029046-2024-01114
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/02/2024

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: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/02/2024
• 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: BAYLIS NEEDLE.; CARTO 3 SYSTEM.; LASSOSTARNAV,10P,20MM DIA LOOP.; UNKNOWN CS CATHETER.; UNKNOWN GENERATOR.; UNKNOWN PUMP.; UNK_SOUNDSTAR.
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male