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 Crack (1135)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection noted a cracked luer.Electrical tests revealed no electrical opens or shorts nd all electrodes, sensor and thermocouple resistances were in specification and were typical.All impedance and temperature readings were normal.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 device's lumen was leak tested using an isaac pressure decay test system set to 107 psi, and a touhy bourst seal for sealing the irrigation holes and me's.The lumen pressure decay was measured three times.Lumen pressure decay values indicated a gross leak due to the cracked luer.After the luer crack was sealed with adhesive lumen pressure decay values were below the maximum limit.X-ray examination revealed kink in the magnetic sensor wires located approximately 45.5 centimeters from the distal end.

Event Description

Reportable based on device analysis completed on june 16 2021.During an ablation procedure a intellanav mifi open-irrigated (oi) catheter was selected for use.It was reported that after approximately 45 minutes in vivo, high frequency and high amplitude noise was observed on electrogram channels on both rhythmia and the recording system.The noised ceased once the intellanav mifi oi catheter was disconnected from the new intellanav cable.The physician then reconnected the cable and the noise appeared again.There appeared to be some play in the connection and the physician felt a 'second click' when attaching the intellanav cable.The severity of the noise changed with manipulating the catheter handle at the junction of the port which connects the intellanav cable.The catheter was then replaced for another intellanav mifi oi catheter and the procedure was completed with no patient complications.However, device analysis revealed a cracked luer.

• 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: 12174898
• MDR Text Key: 261753126
• Report Number: 2134265-2021-09088
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0026692108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Date Manufacturer Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1