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

Model Number 87047

Device Problem Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

Event Description

It was reported, that during a procedure to treat atrial fibrillation.An intellanav mifi open-irrigated catheter was selected for use.The catheter could not reach the target location in the isthmus of the tricuspid ring.The bend of the ablation catheter was too large, resulting in a bend to the maximum angle, that could not reach the bottom of the isthmus.As such, the ablation effect was not satisfactory when it was applied.The catheter was replaced with another of the same model.The procedure was completed with no patient complications.However, analysis of the returned device revealed a cut in the catheter shaft.

Manufacturer Narrative

The intellanav mifi open-irrigated catheter was returned to boston scientific for laboratory analysis.A visual inspection found a cut in the catheter shaft.The functional test found the steering knob and the tension control knob functioned properly in both the lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.A dimensional test found that both right and left curves reach the specified area of the test template.The reported curve defections issues were confirmed through analysis.Initial reporter phone:+(b)(6).

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Type of Device: 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: 17083115
• MDR Text Key: 316760950
• Report Number: 2124215-2023-24944
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0029287975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 55 KG