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 Improper Flow or Infusion (2954)

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

Event Date 07/22/2021

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 de-novo pulmonary vein isolation paroxysmal procedure.During preparation of the catheter it was noted that the flush ports of the catheter remained occluded after increasing pressure from the infusion bag.Even using the syringe with lots of pressure effects only 2-3 fluid drops from the catheter ports, which remained occluded after reconnection to the infusion bag.Fluid connection cables were also checked for bending, but it was connected properly.The catheter was replaced and the procedure was completed with no patient complications.The device is expected to be returned for analysis.

Event Description

It was reported that a intellamap orion high resolution mapping catheter was used in a de-novo pulmonary vein isolation paroxysmal procedure.During preparation of the catheter it was noted that the flush ports of the catheter remained occluded after increasing pressure from the infusion bag.Even using the syringe with lots of pressure effects only 2-3 fluid drops from the catheter ports, which remained occluded after reconnection to the infusion bag.Fluid connection cables were also checked for bending, but it was connected properly.The catheter was replaced and the procedure was completed with no patient complications.The device has been returned for analysis.

Manufacturer Narrative

Visual inspection of the device showed no major issues noted.During irrigation testing with a meriq pump, the device could not irrigate beyond 4ml/min before an occlusion error would occur.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.

• 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: 12267867
• MDR Text Key: 264765703
• Report Number: 2134265-2021-09954
• 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: 10/14/2021

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: 07/27/2022
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0026690900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 10/14/2021
• Patient Sequence Number: 1