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 Obstruction of Flow (2423)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that during the preparation of an ablation procedure to treat a paroxysmal supraventricular tachycardia (psvt) in the left atrium, an intellamap orion high resolution mapping catheter was selected for use.The irrigation tube was connected during preparation, but the water droplets did not flow because the "circuit" was blocked.No error messages displayed.The flow rate was 60ml/min speed with the infusion pump.The device was replaced with another lot of the device and the procedure was completed successfully without any patient complications.Catheter is expected to be returned for further analysis.

Manufacturer Narrative

Intellamap orion high resolution mapping catheter was evaluated by boston scientific.Analysis of returned product revealed that the device showed no evidence or defects that could have contributed to the reported event.Laboratory analysis was unable to confirm the reported clinical observation of obstruction within device.Device was found within specifications.

Event Description

It was reported that during the preparation of an ablation procedure to treat a paroxysmal supraventricular tachycardia (psvt) in the left atrium, an intellamap orion high resolution mapping catheter was selected for use.The irrigation tube was connected during preparation, but the water droplets did not flow because the "circuit" was blocked.No error messages displayed.The flow rate was 60ml/min speed with the infusion pump.The device was replaced with another lot of the device and the procedure was completed successfully without any patient complications.Catheter was returned for laboratory 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: 19027456
• MDR Text Key: 339210813
• Report Number: 2124215-2024-19972
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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: 0031127565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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