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 10/11/2023

Event Type  malfunction  

Event Description

It was reported that during preparation for a procedure using an intellamap orion high resolution mapping catheter (orion) irrigation was not possible.When they connected the catheter to the saline drip bag no fluid came from the tip of the catheter.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheter is expected to be returned for analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was visually inspected, and no abnormalities were noted.Next, they tested the irrigation of the catheter and identified a leak.When investigators deconstructed the catheter, they found the source of the leak was adhesive on irrigation tubing had become damaged the reported allegation of irrigation failure was confirmed, and the root cause for the occlusion was traced to component failure due to the damage noted on the adhesive.Separated tubing would prevent irrigation fluid from entering the catheter and proper irrigation would be unable to occur.

Event Description

It was reported that during preparation for a procedure using an intellamap orion high resolution mapping catheter (orion) irrigation was not possible.When they connected the catheter to the saline drip bag no fluid came from the tip of the catheter.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheter has been received 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
• 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: 18030238
• MDR Text Key: 326858904
• Report Number: 2124215-2023-60085
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

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: 0030698326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 110 KG