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	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during an ablation procedure to treat atrial fibrillation (afib), an intellanav mifi oi catheter was selected for use.During ablation the catheter could not be visualized on the rhythmia hdx mapping system.The ablation cable was replaced, and this did not resolve the problem.The ablation catheter was replaced and the problem was resolved.Upon removal and inspection of the catheter a breach in the catheter shaft was found.During the procedure no resistance was felt while maneuvering this catheter.The damage was not noticed before the catheter was inserted into the patient.No fragments were left in the patient and no interventions were needed to retrieve any pieces of the device from inside the body.The catheter was replaced and the procedure was completed without any patient complications.The catheter is expected to be returned for laboratory analysis.
Additional Manufacturer Narrative
Additional information received on 28mar2023, indicated that there was an intermittent magnetic tracking failure.The mapping system used was rhythmia hdx, software version: 4.5.No other error messages were observed during the procedure.This intellanav mifi oi catheter was received by boston scientific and a laboratory analysis was performed.Visual inspection revealed a cut in the catheter shaft.Functional testing was performed; 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.Electrical and continuity testing were performed, and the device showed all results were within specifications.Additional testing was conducted, the device was able to complete an ablation without any difficulties.Laboratory analysis was able to confirm the reported clinical observation regarding "tears/rips/holes/sep dev matrl" was confirmed.For the "tracking/accuracy issue" event the device showed no evidence or defects that could have contributed to this specific issue.
Event or Problem Description
It was reported that during an ablation procedure to treat atrial fibrillation (afib), an intellanav mifi oi catheter was selected for use.During ablation the catheter could not be visualized on the rhythmia hdx mapping system.The ablation cable was replaced, and this did not resolve the problem.The ablation catheter was replaced and the problem was resolved.Upon removal and inspection of the catheter a breach in the catheter shaft was found.During the procedure no resistance felt while maneuvering this catheter.The damage was not noticed before the catheter was inserted into the patient.No fragments were left in the patient and no interventions were needed to retrieve any pieces of the device from inside the body.The catheter was replaced and the procedure was completed without any patient complications.The catheter has been returned for laboratory 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: 16637752
• Report Number: 2124215-2023-13867
• Device Sequence Number: 12067146
• Product Code: OAD
• UDI-Device Identifier: 08714729938385
• UDI-Public: 08714729938385
• 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): 04/27/2023

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: 11/16/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030557241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown