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	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intellanav mifi open-irrigated ablation catheter was returned to boston scientific for analysis.Visual inspection presents a cut in the catheter shaft, at approx.11cm from the distal tip.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 right and left curves are placed in the template shaded areas; the device passed the dimensional testing.Complaint was not confirmed through cis analysis for bad/poor curve.However, a secondary finding was observed with cut in the catheter shaft.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.
Event or Problem Description
Reportable based on analysis completed on 25 september 2023.It was reported that during a radiofrequency ablation procedure to treat atrial flutter (af) an intellanav mifi open-irrigated catheter was selected for use.It was noted while inside the patient anatomy, that there was damage to the curve portion of the catheter.The catheter could not bend properly.No resistance was felt while maneuvering the catheter.The patient did not have any unusual or tortuous anatomy.The physician did not used sheaths, the incident occurred after the packaging was unpacked.The device was replaced, and the procedure was completed successfully without patient complications.The catheter was returned for analysis.Complaint was not confirmed through cis analysis for bad/poor curve.However, a secondary finding was observed with cut in the catheter shaft.

• 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: 17976711
• Report Number: 2124215-2023-58343
• Device Sequence Number: 3568319
• Product Code: OAD
• UDI-Device Identifier: 08714729938385
• UDI-Public: 08714729938385
• 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): 10/20/2023

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: 11/09/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030519180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown