MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

Device Problem Data Problem (3196)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

Intellamap orion catheter was evaluated by boston scientific.Visual inspection noted that the magnetic sensor is broken.The steering knob and the tension control knob functioned properly on both lock and unlock positions.Deployment slider functioned properly, and the basket shape was formed.No abnormal resistance was felt when executing the steering mechanism and deployment system.Analysis of returned product revealed that the magnetic sensor is broken causing that this component was found electrical open, consequently confirming the reported event.The most probable conclusion code is "cause traced to component failure" since the failure found indicates the possibility that the magnetic sensor is in malfunction or damaged.

Event Description

It was reported that during a cavotricuspid isthmus ablation procedure a intellamap orion catheter was selected for use.When the catheter was introduced into the body signal were visible, however, the orion could not be visualized and the console displayed the error message "error 114-2: the orion magnetic sensor is either disconnected or broken".The signal station was restarted and the umbilical cable replaced, but the issue persisted.The catheter was replaced and the procedure was completed successfully.No patient complications were reported.The device has been received at boston scientific post market laboratory.Analysis of the returned device found that the magnetic sensor is physically broken.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 18499482
• MDR Text Key: 333202198
• Report Number: 2124215-2023-75484
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2024

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
• Device Operator: Health Professional
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0031800724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1