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 Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radiofrequency cardiac ablation procedure, an intellanav mifi catheter was selected for use.The console prompted the catheter did not connect.Catheter was replaced as well as the radiofrequency meter accessories and problem was resolved, however procedure was cancelled due to this event while the patient was sedated with anesthesia.The device is expected to be returned for further analysis.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).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 or Problem Description
It was reported that during a radiofrequency cardiac ablation procedure, an intellanav mifi catheter was selected for use.The console prompted the catheter did not connect.Catheter was replaced as well as the radiofrequency meter accessories and problem was resolved, however procedure was cancelled due to this event while the patient was sedated with anesthesia.The device is expected to be returned for further analysis.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).The intellanav mifi open-irrigated catheter was evaluated by boston scientific.The device does not have visual defects.Functional test shows that the plunger functioned properly.No abnormal resistance was felt when actuating the steering mechanism.The continuity test was performed, and the device was found within specifications.No open or shorts were detected.Lastly, the device was recognized by rhythmia hdx system and showed no evidence of issues.Laboratory analysis was unable to confirm the reported clinical observation of recognition issues.Device was found within specifications.

• 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: 18669308
• Report Number: 2124215-2024-04546
• Device Sequence Number: 20631598
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: 11/24/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030602313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 68 KG