MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004PMR9620K20

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

Patient age: 18 years or older.Device evaluated by manufacturer - visual inspection revealed that the distal end had a slight left curve after the steering knob was returned to neutral.Dried body fluid was found under the edges of ring 1 & 3 electrodes.Dried body fluid also found on the handle, main body, distal end and inside the luer fitting/tubing.Dried saline was found on the distal end and inside the irrigation ports.Electrical continuity checks revealed no electrical opens or shorts, as checked manually using a multi-meter and breakout box.All electrodes, sensor and thermocouple resistances measured in spec and were typical.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Connected device to a maestro 4000 to measure tip temperature.During 5 minutes at room temperature (22.0c), the maestro displayed 22c.After soaking 5 minutes in a tank of 37.0c saline, the maestro displayed 37c.Ablation was verified by using a maestro generator 4000, a metriq pump, and a tank of 37c saline solution.Occlusion errors occurred on the pump display, so ablation testing was performed on the bench without irrigation connected.The device was found within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Reportable based on analysis completed on 29aug2018.It was reported that during and atrial fibrillation ablation procedure with an intellanav mifi open-irrigated ablation catheter a "temp out of range" error occurred.Changing the cables did not resolve it.The catheter was switched to a new of the same ablation catheter and it worked fine.No patient complications occurred.However; returned device analysis revealed body fluid was found under the edges of ring 1 & 3 electrodes.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7888944
• MDR Text Key: 120712070
• Report Number: 2134265-2018-07451
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2020
• Device Model Number: M004PMR9620K20
• Device Catalogue Number: PMR9620K2
• Device Lot Number: 21836647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2018
• 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