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 Loss of or Failure to Bond (1068); Material Integrity Problem (2978)

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

It was reported that catheter tip was torn.It was reported that during an ablation procedure to treat an atrial flutter (afl) on the left atrium, an intellamap orion catheter was selected for use.During the further course of the procedure, the physician noticed a broken articulation tension adjustment knob (handle), it was not possible to deflect the catheter curve anymore.Visual inspection showed a bent respectively torn catheter tip.Catheter was replaced and the issue was resolved.Procedure was completed successfully with no patient complications.Catheter is expected to be returned for laboratory analysis.

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 catheter tip was torn.It was reported that during an ablation procedure to treat an atrial flutter (afl) on the left atrium, an intella map orion catheter was selected for use.During the further course of the procedure, the physician noticed a broken articulation tension adjustment knob, it was not possible to deflect the catheter curve anymore.Visual inspection showed a bent respectively torn catheter tip.The physician did not report a resistance with the catheter.The patient did not have any unusual or tortuous anatomy.Catheter was replaced and the issue was resolved.Procedure was completed successfully with no patient complications.Catheter is expected to be returned for laboratory analysis.

Manufacturer Narrative

The device has not been received for analysis.However, pictures were provided in the complaint, and it is possible to observe a defective curve, also the device has a kink at curve section of the catheter shaft.Based on all the available information boston scientific concluded the tip damage event was confirmed, and it may be related with some other factors such as excessive handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance and its integrity.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.

Manufacturer Narrative

Analysis of product returned, and pictures attached, and it is possible to observe a kink at curve section of the catheter shaft.Also, product analysis revealed that the turning / tension knob was detached and fell off of the return device.Therefore, the reported events are confirmed.

Event Description

It was reported that catheter tip was torn.It was reported that during an ablation procedure to treat an atrial flutter (afl) on the left atrium, an intellamap orion catheter was selected for use.During the further course of the procedure, the physician noticed a broken articulation tension adjustment knob, it was not possible to deflect the catheter curve anymore.Visual inspection showed a bent respectively torn catheter tip.The physician did not report a resistance with the catheter.The patient did not have any unusual or tortuous anatomy.Catheter was replaced and the issue was resolved.Procedure was completed successfully with no patient complications.Catheter is expected to be 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: 18005437
• MDR Text Key: 326519896
• Report Number: 2124215-2023-58809
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

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 Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0031415334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 10/30/2023; 12/07/2023
• Supplement Dates FDA Received: 11/17/2023; 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1