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

Model Number M004RC64S0

Device Problems Signal Artifact/Noise (1036); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2018

Event Type  malfunction  

Event Description

Reportable based on analysis completed on 02-oct-2018.It was reported that noisy proximal electrodes were noted during mapping.During a ventricular tachycardia ablation procedure with a intellamap orion catheter, more and more proximal electrode became noisy while mapping.The electrodes were disabled.The procedure was completed with another intellamap orion catheter.No patient complications were reported and the patient's current condition is fine.However, analysis revealed peeling of the deployment shaft.Visual inspection shows 3 kinked near the handle strain relief.The electrical test was performed and the device failed the test.Both the magnetic sensory resistance and inductance test are within specifications.The reported failure of proximal electrodes loss was confirmed through analysis.The device is seen to have organic damage cause by normal use of the device over a prolonged period.The deployment shaft peeling is present.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 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: 8025565
• MDR Text Key: 125699566
• Report Number: 2134265-2018-62326
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2018

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 Expiration Date: 05/07/2019
• Device Model Number: M004RC64S0
• Device Catalogue Number: 87035
• Device Lot Number: 0022086840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1