MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 87047

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.The reported failure was confirmed through analysis.Visual inspection noted dried saline on the luer and distal tip.Continuity checks revealed no electrical opens or shorts and 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.The device's lumen was leak tested and it did not pass.Bench testing revealed that the impedance between the tip and thermocouple and/or sensor wires remained electrically open when the tip was immersed in saline.Dissection of the device noted evidence of fluid ingress where the lumen leaves the handle.Dried saline crystals were also visible in the interior of the catheter.The complaint investigation conclusion code is design inadequate for purpose.

Event Description

Reportable based on device analysis completed on 10/07/2020.During an ablation procedure to treat left atypical flutter a intellanav mifi open-irrigated ablation catheter was selected for use.It was reported that the catheter was not recognized by the maestro pod during ablation.Error message d10 "invalid catheter id" was observed.The user replaced the cable and the pod but the error persisted.The procedure was continued successfully by exchanging the catheter.No patient complications were reported.However, device analysis revealed a fluid leak is observed between the lumen and the catheter handle.

• 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 CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 10719476
• MDR Text Key: 212544234
• Report Number: 2134265-2020-14624
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2020
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0022704744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1