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 03/08/2022

Event Type  malfunction  

Event Description

Reportable based on analysis on september 23rd 2022.Prior to a procedure to treat atrial fibrillation, an intellanav mifi open-irrigated was selected for use.It was reported that when the physician unpacked the catheter, it was found that the catheter was damaged.Procedure was completed with another of same device.No patient injury reported.However, returned device analysis revealed a cut in the proximal part of the catheter shaft.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Per visual inspection, the device present a bent/kin in the proximal part of the catheter shaft, near to the handle and there is a cut in the proximal part of the catheter shaft.Device passed functional test since 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.Dimensional test showed that both right and left curves reached the specified area of the template.Flow test was performed and all six irrigation ports flow freely.The pump was programmed to 30ml/min and the device was irrigated for 5 minutes without any errors or pump messages.Continuity test showed that device was found within specifications.The noise signals of the device were verified during an rf ablation test and the device was able to complete an rf ablation test at cooling flow set to 17 ml/min at power at 50w for 10s with average readings for electrogram noise during rf < 142 vrms.Noise values were found typical and within specifications.

• 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: 15543461
• MDR Text Key: 304532740
• Report Number: 2124215-2022-39648
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0028332470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 78 KG