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 Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2021

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

It was reported that a intellamap orion high resolution mapping catheter was used in a atrial tachycardia procedure.As the catheter was removed from the patient, one spline on the catheter remained opened with the central "blade" of the catheter was twisted.The catheter was replaced with another orion with no patient complications being reported.

Manufacturer Narrative

The device was returned to boston scientific for analysis.The reported observation of the damaged deployment shaft was confirmed through investigational analysis.Visual inspection revealed a kink in the deployment shaft near the distal end.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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that a intellamap orion high resolution mapping catheter was used in a atrial tachycardia procedure.As the catheter was removed from the patient, one spline on the catheter remained opened with the central "blade" of the catheter was twisted.The catheter was replaced with another orion with no patient complications being reported.

• 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: 11464621
• MDR Text Key: 239194207
• Report Number: 2134265-2021-03202
• 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: 06/09/2021

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: 07/29/2021
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0025116873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 06/09/2021
• Patient Sequence Number: 1