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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stenosis (2263)

Event Date 03/31/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: information received indicates that the device is not available for return, 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 4.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).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered pulmonary vein stenosis post ablation.Consequences of stenosis of left pulmonary veins in the patient were observed post-op, 3 months after the operation.The procedure occurred on (b)(6) 2022.Stenosis of left pulmonary veins was noticed during a computed tomography (ct) angiography / heart scan of control (this exam is always done 3 months after the procedure).Patient was without symptoms.The patient did not experience a post-op device malfunction.The patient did not require revision surgery or hardware removal.No other medical intervention was required.Additional information was received indicated the bwi representative was made aware of that the patient suffered a pulmonary vein stenosis after it was discovered with the routine follow up and ct scan.The physician¿s opinion on the cause of this adverse event is that it was due to ablation procedure as line seems to be too ostial.No intervention has provided.Patient will undergo close follow up.The patient did not present with any symptoms.The patient outcome of the adverse event is unchanged.The patient did not require extended hospitalization because of the adverse event.Graph, dashboard, vector, and visitag force visualization features were used.Parameters for stability used with visitag were 3mm stability, time 3sec, force over time (fot) of 3grams, 25% time.Respiration additional filter was used with the visitag and ftpi color option.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15247042
• MDR Text Key: 298114541
• Report Number: 2029046-2022-01906
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2022
• 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
• Treatment: CARTO 3 SYSTEM; PENTARAY NAV ECO 7FR, F, 2-6-2
• Patient Outcome(s): Other