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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2020

Event Type  malfunction  

Event Description

It was reported that a intellamap orion high resolution mapping catheter was used in a atrial flutter ablation procedure.It was reported that the device was difficult to contract.It was reported that there was no damage or patient complications.It was further reported that the catheter array was difficult to un-deploy.

Event Description

It was reported that a intellamap orion high resolution mapping catheter was used in a atrial flutter ablation procedure.However it was reported that the device was difficult to contract.It was reported that there was no damage or patient complications.It was further reported that the catheter array was difficult to un-deploy.

Manufacturer Narrative

Visual inspection of the device showed there was a kink that could have affected deployment.The slider switch had no issues noted in the investigation.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• 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: 11060009
• MDR Text Key: 223385194
• Report Number: 2134265-2020-18366
• 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: 03/02/2021

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: 05/07/2021
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0024723647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1