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

Catalog Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, 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 31051084m and no internal action related to the complaint was found during the review.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 reference number: (b)(4).

Event Description

During a clinical trial sponsored by bwi, it was reported that a patient underwent repeat/retreatment ablation procedure on (b)(6) 2023 for atrial tachycardia.Patient had a chads2vasc score of 3, and history of hypertension and paroxysmal fibrillation.On (b)(6) 2023, patient experienced cardiac tamponade categorized as severe and serious as defined by in-patient or prolonged hospitalization and medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function.Patient was admitted to the hospital (b)(6) 2023 and discharged from the hospital (b)(6) 2023.Relationship to study device is causal and relationship to primary study procedure is causal relationship to the repeat/retreatment procedure.The adverse event is expected/anticipated.The outcome is recovering/resolving.Intervention was "pericardial punction" on (b)(6) 2023, patient also experienced pericarditis constrictiva categorized as moderate and serious as defined by prolonged hospitalization with an admission date of (b)(6) 2023.Relationship to study device is probable and relationship to primary study procedure is causal relationship to the repeat/retreatment procedure.The adverse event was expected / anticipated.The outcome is not recovered / resolved.Intervention was medication.On (b)(6) 2023, patient experienced bilateral pneumonia categorized as moderate and not serious.Relationship to study device is not related and relationship to primary study procedure is probable relationship to the repeat/retreatment procedure.The outcome is recovered/resolved with an end date of (b)(6) 2023.Intervention was medication.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.

Manufacturer Narrative

On 27-oct-2023, bwi received additional information indicating that the patient's outcome improved.The initial report started that the patient's cardiac tamponade was in the process of recovering/resolving.The new information indicates that the incident has fully recovered and resolved as of (b)(6) 2023.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¿ 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: 17690960
• MDR Text Key: 322740249
• Report Number: 2029046-2023-02004
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Device Lot Number: 31051084M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2023
• 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
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 76 KG