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 05/12/2021

Event Type  malfunction  

Event Description

It was reported that during preparing for a mapping procedure using a intellamap orion high resolution mapping catheter there were difficulties with the irrigation of the catheter.Prior to insertion into the patient irrigation was tested and they found there was no saline flow from the tip.It was reported the catheter was replaced and the procedure was completed.There were no patient complications and the patient was reported to have been stable throughout and after the procedure.The catheter has been received by boston scientific for analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was first visually inspected and no abnormalities were found.Next the irrigation of the catheter was tested and the catheter's irrigation was within normal specifications.In addition, review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Also, a review of the use documents found no evidence of the device being used in a manner inconsistent with the labeled indications.With all available information the complaint could not be confirmed as the reported failure was not able to be reproduced and the device presented with no issues.

Event Description

It was reported that during preparing for a mapping procedure using a intellamap orion high resolution mapping catheter there were difficulties with the irrigation of the catheter.Prior to insertion into the patient irrigation was tested and they found there was no saline flow from the tip.It was reported the catheter was replaced and the procedure was completed.There were no patient complications and the patient was reported to have been stable throughout and after the procedure.The catheter has been received by boston scientific 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: 11872669
• MDR Text Key: 252338086
• Report Number: 2134265-2021-06714
• 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: 07/23/2021

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: 07/31/2022
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0026720451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1