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 03/08/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and during ablation phase, the patient experienced cardiac tamponade that required pericardiocentesis and prolonged hospitalization.Blood pressure was low from the beginning of the procedure and there was a possibility of atrial fibrillation, so the physician did not confirm effusion.The physician had difficulty with the brockenbrough.Atrial fibrillation was terminated during pulmonary vein isolation (pvi), but blood pressure did not stabilize, and effusion was checked by echocardiography.Subsequently, pericardial fluid was confirmed.After pulmonary vein isolcation (pvi), superior vena cava (svc) isolation, and cavotricuspid isthmus (cti), drainage was performed, and patient was in good condition and was monitored in the intensive care unit (icu).According to the physician, "we had difficulty with brockenbrough and cardiac tamponade might have occurred at that time." no abnormalities were observed prior to or during use of the product.Additional information received indicated that the patient has improved.Transseptal puncture was performed.Ablation was performed prior to noting the pericardial effusion.No error messages were observed on biosense webster equipment during the procedure.

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).

Manufacturer Narrative

Additional information was received on 11-apr-2024.It was reported that there was no evidence of steam pop.It was also reported that a transseptal puncture was performed with a radiofrequency (rf) needle.The generator product details were also provided.Therefore, the concomitant product section was updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) additional information was received on 11-apr-2024.It was reported that the patient fully recovered and did not require extended hospitalization.Therefore, the code of hospitalization or prolonged hospitalization (f08) has been removed.

• 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: 19044284
• MDR Text Key: 339436675
• Report Number: 2029046-2024-01132
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• 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: 31179872L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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: UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 65 KG