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

Catalog Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/02/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced a cardiac tamponade treated with a pericardiocentesis.Atrial septal puncture was performed.Ablation was performed only for cavotricuspid ishmus (cti) at 40w before pericardial effusion or tamponade was confirmed.Box isolation was performed with cryo ablation catheter.Steam pop was not confirmed.There was no decrease in patient¿s blood pressure etc.In the final phase of the procedure, additional doses of adetphos were administered.After the additional doses, the patient's st increased sharply.After adetphos was administered, the patient's blood pressure dropped to the 40s.Coronary angiography (cag) was performed, nitroglycerin was administered, the patient¿s blood pressure decreased, and the pericardial effusion was confirmed by echocardiography.Pericardial drainage was performed, and the patient left the room to intensive care unit (icu).The physician's opinions on the relationship between the event and the product is that it was unclear whether the perforation was in the right or left atrium.The causal relationship was also unclear.Radiology records: cti 14:04~, adetphos was administered 14:15.13:18 the patient¿s heart rate was confirmed.14:11 it was confirmed the patient¿s heart rate decreased.14:40 the pericardial effusion was confirmed.No abnormalities observed prior to or during use of the product.

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 was performed for the finished device number lot 31173570l and no internal action related to the complaint was found during the review.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 18794211
• MDR Text Key: 336395807
• Report Number: 2029046-2024-00657
• Device Sequence Number: 1
• Product Code: LPB
• 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: Other
• Type of Report: Initial
• Report Date: 02/27/2024

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: D134801
• Device Lot Number: 31173570L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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: CARTO 3 SYSTEM; DEF, 7F, VARI, 10P,REDEL; OCTA,STD,48P,2-2-2-2-2,D-CURVE; SOUNDSTAR ECO SMS 8F CATHETER; UNKNOWN CRYO ABLATION CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 49 KG