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 Difficult to Remove (1528); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

It was reported that the wire sensor in the center of the basket on the intellamap orion high resolution mapping catheter was damaged.A disconnection of the deployment shaft/ wire was observed when the catheter was checked outside the patient.The orion was pulled out together with the sheath, as the array could not be pulled into the sheath.This event occurred at the end of the procedure and the procedure was completed using the device.No patient complications reported.Product has been returned for analysis.

Event Description

It was reported that the wire sensor in the center of the basket on the intellamap orion high resolution mapping catheter was damaged.A disconnection of the deployment shaft/ wire was observed when the catheter was checked outside the patient.The orion was pulled out together with the sheath, as the array could not be pulled into the sheath.This event occurred at the end of the procedure and the procedure was completed using the device.No patient complications reported.Product has been returned for analysis.

Manufacturer Narrative

The intellamap orion high resolution mapping catheter was received and analyzed.It is possible to see that the deployment system support was bend and detached at distal end of the catheter causing that the magnetic sensor wire was detached.Also, the deployment slider was detached, consequently confirming the reported complaint events.This might be related with some other factors such as; excessive handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance and its integrity.

• 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: 17005557
• MDR Text Key: 315963839
• Report Number: 2124215-2023-26378
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

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: 0030740487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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