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

Model Number 87035

Device Problems Device Displays Incorrect Message (2591); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the device showed that the device has saline on the main shaft and in the distal tip.The magnetic sensor is cracked at.245 inches.X-ray confirmed broken sensors.No electrical open failures that appeared in electrodes.No un-allowed shorts occurred in the electrodes.

Event Description

Reportable based upon analysis completed on 05feb2020.It was reported that a sensor error occurred.During a procedure with a intellamap orion catheter when inserted into the heart, an error stating that the sensor magnetic on orion was broken.The catheter was exchanged and the issue was resolved with no patient complications being reported.Upon analysis it was noted that the magnetic sensor was physically cracked.

• 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: 9787347
• MDR Text Key: 182207330
• Report Number: 2134265-2020-02575
• 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: 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0023269712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1