MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: analysis of the returned device found the deployment shaft and magnetic sensor wires separated due to overload force.Electrical testing was performed and the device failed the test.The magnetic sensor resistance and inductance measurements were within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).

Event Description

Reportable based on analysis completed april 10, 2018.It was reported that when the intellamap orion¿ mapping catheter was connected, an error message appeared indicating the magnetic sensor was either disconnected or broken.Signals were visible, but the catheter was not tracked or displayed on the rhythmia mapping system.Replacing the catheter resolved the issue.There were no patient adverse events.However, returned device analysis found the deployment shaft had separated.

• Brand Name: INTELLAMAP ORION¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7464236
• MDR Text Key: 106634411
• Report Number: 2134265-2018-03707
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122461
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2018
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 21130129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MAPPING SYSTEM: BOSTON SCIENTIFIC RHYTHMIA