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

Model Number	87047
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter luer lock connection was fractured and was leaking fluid.During a procedure to treat atrial fibrillation (a fib) an intellanav mifi oi 7.5/110/2.5/4.5 k2 was selected for use.During ablation the maestro 4000 generator alarmed an "excessive temperature" warning.The flow rate was 17ml/min.When the catheter was inspected after the alarm it was found that the luer lock connection was fractured and leaking fluid.The catheter was exchanged for another of the same model.The procedure was completed with no patient complications.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The intellanav mifi open-irrigated catheter was returned to boston scientific for laboratory analysis.Visual inspection found the irrigation extension tubing was detached/separated from the luer fitting at the adhesive joint.The functional test revealed 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.Laboratory analysis confirmed the reported clinical observation.
Event or Problem Description
It was reported that the catheter luer lock connection was fractured and was leaking fluid.During a procedure to treat atrial fibrillation (a fib) an intellanav mifi oi 7.5/110/2.5/4.5 k2 was selected for use.During ablation the maestro 4000 generator alarmed an "excessive temperature" warning.The flow rate was 17ml/min.When the catheter was inspected after the alarm it was found that the luer lock connection was fractured and leaking fluid.The catheter was exchanged for another of the same model.The procedure was completed with no patient complications.The device has been returned for analysis.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Common Device Name: 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: 15771920
• Report Number: 2124215-2022-45521
• Device Sequence Number: 15108530
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150005/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030004644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown