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

Model Number 87047

Device Problem Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

During a procedure to treat atrial fibrillation in the left atrium, a intellanav mifi open-irrigated catheter was selected for use.It was reported that the irrigation port is broken.The procedure was completed successfully by replacing the device with another intallanav mifi oi catheter.No patient complications were reported and the patient's current condition is fine.

Manufacturer Narrative

With all the available information, boston scientific concludes the reported failure of broken irrigation tube was not confirmed through investigational analysis.Visual inspection did not reveal any visible damages.Dried saline was on the luer and dried bodily fluids were noted on the catheter shaft.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 the values are within an acceptable limit.Additional, all irrigation ports of the catheter were verified to be functioning.Power, temperature, impedance and noise measurements were as expected with no error codes or warnings during radiofrequency ablation test.The device passed all relevant testing/inspection.The complaint investigation conclusion code is design inadequate for purpose.The design inadequate for purpose conclusion code was selected based on the direct observation of opens or shorts attributed to open or broken sensors.Open or broken sensors are considered a design issue when the field report indicates the damage occurred during normal use.

Event Description

During a procedure to treat atrial fibrillation in the left atrium, a intellanav mifi open-irrigated (oi) was selected for use.It was reported that the irrigation port is broken.The procedure was completed successfully by replacing the device with another intallanav mifi oi catheter.No patient complications were reported and the patient's current condition is fine.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• 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
• MDR Report Key: 10634841
• MDR Text Key: 209991428
• Report Number: 2134265-2020-13771
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (y/n): N
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

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: 09/04/2021
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0024382985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1