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

Catalog Number D134702

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Cardiac Tamponade (2226)

Event Date 10/19/2023

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.Investigation is in progress, once completed a supplemental will be submitted.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).

Event Description

During a clinical trial, it was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered a cardiac tamponade and bradycardia, which required medication, pacemaker implantation and prolonged hospitalization.Patient received a cardiac ablation on (b)(6) 2023 (index procedure) under conscious sedation.On (b)(6) 2023, patient experienced, cardiac tamponade, categorized as moderate severity.This is considered a serious event due to serious deterioration in the health of the subject as defined by a life threatening illness / injury and prolonged hospitalization (admission date (b)(6) 2023).Relationship to study device is not related and relationship to primary study procedure is causal relationship to the index procedure.The adverse event is expected/anticipated.The outcome is not recovered/not resolved.Intervention was medication.On (b)(6) 2023, patient experienced ae#2, bradycardia, categorized as moderate severity.This is considered a serious event due to serious deterioration in the health of the subject as defined by prolonged hospitalization (admission date (b)(6) 2023).Relationship to study device is not related and relationship to primary study procedure is causal relationship to the index procedure.The adverse event is expected/anticipated.The outcome is not recovered/not resolved.Intervention was surgery (pacemaker implantation).

Manufacturer Narrative

Additional information was received for the adverse event of cardiac tamponade on (b)(6) 2023.The discharge date was (b)(6) 2023.Additional information was received for the adverse event of cardiac tamponade on (b)(6) 2023.The cardiac tamponade was categorized as severe.Relationship to study devices is causal relationship to both the thermocool® smart touch® sf uni-directional navigation catheter and the pentaray nav high-density mapping eco catheter.Since the pentaray nav high-density mapping eco catheter relationship to study device for the cardiac tamponade adverse event is updated to casual, this adverse event is now also assessed as mdr reportable under the pentaray nav high-density mapping eco catheter.The awareness date for the pentaray nav high-density mapping eco catheter report is (b)(6) 2023.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-02638 for product code d134702 (thermocool® smart touch® sf uni-directional navigation catheter).(2) mfr # 2029046-2023-03032 for product code d128208 (pentaray nav high-density mapping eco catheter) the investigation was completed on (b)(6) 2023.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 31122872l number, 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).

Manufacturer Narrative

Additional information was received for the adverse event of cardiac tamponade on (b)(6) 2024.The outcome is recovered/resolved.Additional information was received for the adverse event of bradycardia on (b)(6) 2024.The discharge date was (b)(6) 2023.The outcome is recovered/resolved.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 UNI-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: 18137005
• MDR Text Key: 328109407
• Report Number: 2029046-2023-02638
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134702
• Device Lot Number: 31122872L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• 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: NGEN RF GENERATOR.; PENTARAY NAV ECO 7FR, F, 2-6-2.; UNK_CARTO 3.
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male