MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stenosis (2263)

Event Type  Injury  

Event Description

It was reported a patient underwent a cardiac ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and patient experienced pulmonary vein stenosis.After ablation, pulmonary vein stenosis occurred and explanation to the patient has been requested.The patient underwent ablation (abl) in 2011, so it is unknown which products were used.It is not possible to confirm how long after abl the event occurred.The patient was conducted ablation in 2011, which resulted in pulmonary vein stenosis.The event was revealed when the carto3 image was requested from the physician to explain to the patient.There have been no reports received that this was caused by a defect in the biosense webster, inc.Products.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).Additional 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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 18956768
• MDR Text Key: 338307526
• Report Number: 2029046-2024-00976
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008333
• UDI-Public: 10846835008333
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• 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
• Treatment: CARTO 3 SYSTEM WITH CARTO MERGE.
• Patient Outcome(s): Other