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	Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).The intellanav mifi open-irrigated catheter was evaluated by boston scientific.Laboratory analysis of returned product revealed that the device has the shaft partially cut/exposed and also present an electrical open in r1 and tracking issues in the rhtyhmia system, consequently confirming the reported clinical observation of tracking/accuracy issues.Analysis of returned product revealed that the device has the shaft partially cutted/exposed and also present an electrical open in r1 and tracking issues in the rhtyhmia system, it may be related with some other factors such as; handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance and its integrity.
Event or Problem Description
The complaint is reportable upon investigation results; it was reported that during a radiofrequency ablation to treat an atrial tachycardia on the left atrium, an intellanav mifi open-irrigated catheter was selected for use.The catheter shook severely as soon as it discharged.It was further reported that the "shook issue" was a tracking/accuracy problem.No patient complications occurred.Device was returned to boston scientific for laboratory analysis.Upon device analysis, device was found to have the shaft partially cutted/exposed.

• 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: 19332915
• Report Number: 2124215-2024-29744
• Device Sequence Number: 17846560
• 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
• Report Date (Section B): 05/16/2024

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: 11/21/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030584123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 71 KG