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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Event Description

During a atrial fibrillation ablation procedure a intellamap orion catheter was selected for use.It was reported that flushing from the catheter side port could not be completed, a syringe was connected and tried again, but again was unable to flush.The catheter was exchanged for another orion catheter and the procedure was completed successfully without any patient complications.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection noted a kink in the main shaft near the distal end.The device irrigation was leak tested and pressure was applied to the unit.Pressure was held for 30 seconds, which indicated a blockage.The device was irrigated with saline, however, the saline could not pass or loosen the blockage.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

During a atrial fibrillation ablation procedure a intellamap orion catheter was selected for use.It was reported that flushing from the catheter side port could not be completed, a syringe was connected and tried again, but again was unable to flush.The catheter was exchanged for another orion catheter and the procedure was completed successfully without any patient complications.

• 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: 11591642
• MDR Text Key: 243130588
• Report Number: 2134265-2021-04094
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• 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: 05/13/2021

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: 05/06/2022
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0026302424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/17/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 80