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

Catalog Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Myocardial Infarction (1969); Ventricular Fibrillation (2130); Stenosis (2263)

Event Date 01/18/2024

Event Type  Death  

Event Description

It was reported a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced coronary stenosis.It is possible that this was already the case before, or that it happened as a consequence of the treatment.Insufficient information provided regarding if the stenosis required intervention or treatment.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

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.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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 21-feb-2024, additional information was received indicating the patient required extended hospitalization, but the outcome was death on (b)(6) 2024.Physician's opinion on the cause of the adverse event is that it was patient condition and procedure related.This was a pvc ablation cardiac "vein" near left main.Relevant medical history includes history of mammal carcinoma, radiotherapy.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 3-apr-2024, additional information was received indicating that death occurred few days or hours after (b)(6) 2024 which is when it was learned there had been a complication during the night following the successful pvc ablation.At the time she had an impella and was still alive.Exact date is unknown.The physician's opinion on the cause of death was that the patient had ventricular fibrillation (vf) during the night following the intervention after closure of the coronary which caused an infarction.Ablation of the pvc close to the cardiac vain near left main coronary artery resulted in a stenosis during the night.The patient might have had a reduced lumen already due to the history of radiotherapy which might have contributed to this.The patient received a coronary examination after the ablation and had been kept to the hospital but during the night the vessel occluded and the complications following led to death in the following days.Note: field b2.Date of death has been updated to (b)(6) 2024 as best estimate.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: 18708457
• MDR Text Key: 335407967
• Report Number: 2029046-2024-00504
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• 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
• Patient Outcome(s): Other; Death; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female