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 Improper Flow or Infusion (2954)

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

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during preparation or a procedure using a intellamap orion high resolution mapping catheter there was an obstruction to irrigation flow in the tip of the catheter.They attempted a flush to clear the obstruction but were unsuccessfully.They then exchanged the orion catheter for another of the same model.They were then able to complete the procedure without patient complications.The device is expected to be returned for analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post mark laboratory the catheter was first visually inspected and no abnormalities were found.Next the catheter was functionally tested with a known good pump in order to examine the irrigation.This testing revealed that attempting to irrigate more than 2 l/s resulted in occlusion and an error.With this finding the reported allegation that the catheter became occluded during irrigation attempts was confirmed, however, the root cause of the occlusion could not be determined.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that during preparation for a procedure using a intellamap orion high resolution mapping catheter there was an obstruction to irrigation flow in the tip of the catheter.They attempted a flush to clear the obstruction but were unsuccessfully.They then exchanged the orion catheter for another of the same model.They were then able to complete the procedure without patient complications.The device has been returned for analysis.

• 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
• MDR Report Key: 11629418
• MDR Text Key: 244390600
• Report Number: 2134265-2021-04480
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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: 06/22/2022
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0026552949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1