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 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during a radiofrequency catheter ablation procedure to treat an atrial fibrillation, an intellamap orion high resolution mapping catheter was selected for use.Flow rate used was 60ml/m.After 80 minutes into procedure, procedure was interrupted.No error messages were displayed.It was noticed that the flush port was clogged and it became impossible to continuously flush.The catheter was replaced and the procedure was completed successfully.No patient complications were reported.Catheter is expected to be returned to boston scientific for laboratory analysis.

Event Description

It was reported that during a radiofrequency catheter ablation procedure to treat an atrial fibrillation, an intella map orion high resolution mapping catheter was selected for use.Flow rate used was 60ml/m.After 80 minutes into procedure, procedure was interrupted.No error messages were displayed.It was noticed that the flush port was clogged and it became impossible to continuously flush.The catheter was replaced and the procedure was completed successfully.No patient complications were reported.Catheter is expected to be returned to boston scientific for laboratory analysis.

Manufacturer Narrative

Intellamap orion high resolution mapping catheter was evaluated by boston scientific.Visual inspection noted that the device does not have visual defects.Functional test found the steering knob and the tension control knob functioned properly on both lock and unlock positions.Deployment slider functioned properly, and the basket shape was formed.No abnormal resistance was felt when executing the steering mechanism and deployment system.Flow test noted the device was connected to a metriq pump and was programmed to of 0.5 to 5.0cc per minute and the device was irrigated for 5 minutes without any errors or pump messages.Device was found within specifications.Analysis of returned product revealed that the device showed no evidence or defects that could have contributed to the reported event, consequently not confirming the reported complaint; nevertheless, as per reported information "what was the flow rate? => 60ml/m", the costumer used a flow rate of 60ml/m and the ifu (instructions for use) cites "ensure that fluid is dripping at approximately 1 cc/min through the irrigation line at all times when the catheter is in vivo."; consequently, showing that there was evidence that the device was used in a manner inconsistent with the labeling since a non-recommended flushing was used, therefore for this issue the most probable cause is "failure to follow instructions" since the failure reported were traced to the user not following the manufacturer's instructions.

• 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: 17311801
• MDR Text Key: 319035461
• Report Number: 2124215-2023-36481
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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: 04/21/2024
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0030396055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• 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