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 Activation, Positioning or Separation Problem (2906)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: the second affiliated hospital of guangxi medical university.

Event Description

During a radiofrequency ablation procedure to treat atrial flutter a intellamap orion high resolution mapping catheter was selected for use.It was reported that basket deployment was not possible.The procedure was cancelled and could not be completed due to this event.No patient complications were noted.

Manufacturer Narrative

Initial reporter facility name: (b)(6).The intellamap orion catheter was returned to boston scientific for analysis.Visual inspection did not reveal any anomalies.Magnetic sensor resistance and inductance tests were performed and all values were within range.Mapping, detection, and deployment capabilities were functional.The reported observation of inability to deploy basket was not confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

During a radiofrequency ablation procedure to treat atrial flutter a intellamap orion high resolution mapping catheter was selected for use.It was reported that basket deployment was not possible.The procedure was cancelled and could not be completed due to this event.No patient complications were noted.

• 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
• MDR Report Key: 12248467
• MDR Text Key: 264263081
• Report Number: 2134265-2021-09791
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

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: 03/06/2022
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0025970958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 09/16/2021
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 58