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 Device Displays Incorrect Message (2591); Activation, Positioning or Separation Problem (2906); Mechanics Altered (2984)

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

Event Date 06/10/2021

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

During an atrial flutter procedure to treat tachycardia in the atrium sinistrum a intellamap orion high resolution mapping catheter was selected for use.The basket could not curved and could not be opened or closed, and some electrodes reported error.The catheter was exchanged and the procedure was completed without any patient complications.

Manufacturer Narrative

Upon receipt, this product was thoroughly analyzed in our quality assurance laboratory.Visual examination revealed damage in the main shaft near the distal end.Curve allegation was confirmed as there were kinks affecting the steering.The device failed the planarity test.The deployment complaint was not confirmed as the basket had full functionality and was able to be opened and closed.The electrical complaint could not be confirmed and could not be tested due to the bent pin in the connector.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

During a asl atrial flutter procedure to treat tachycardia in the atrium sinistrum a intellamap orion high resolution mapping catheter was selected for use.The basket could not curved and could not opened or closed, and some electrodes reported error.The catheter was exchanged and the procedure was completed without any patient complications.

• 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: 12143725
• MDR Text Key: 260760415
• Report Number: 2134265-2021-08789
• 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: 08/31/2021

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: 0025971040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/31/2021
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 65