MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

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

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.

Event Description

It was reported that after an ablation procedure had been completed using an intellamap orion high resolution mapping catheter (orion) they found one of the array splines was detached from the distal tip.The procedure had been completed using the original device and the damage was only found when the catheter was withdrawn.No patient complications were reported.The catheter is expected to be returned for analysis.

Manufacturer Narrative

The catheter was not returned to boston scientific for analysis; however, images were provided from the field.Inspection of the photos identified that a spline was detached from one end, at the distal tip of the catheter.The allegation of catheter damage from the field was confirmed.The most likely cause was determined to be an adverse event related to the procedure, as the detached spline likely occurred during use of the catheter during the procedure.

Event Description

It was reported that after an ablation procedure had been completed using an intellamap orion high resolution mapping catheter (orion) they found one of the array splines was detached from the distal tip.The procedure had been completed using the original device and the damage was only found when the catheter was withdrawn.No patient complications were reported.The catheter has not been received for analysis, however, images of the defective catheter were provided and reviewed by investigators.

• 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: 17365238
• MDR Text Key: 319502263
• Report Number: 2124215-2023-38297
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

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: 04/12/2024
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0030331235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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
• Patient Age: 57 YR