MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION METRIQ IRRIGATION TUBING SET; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 86447

Device Problems Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2020

Event Type  malfunction  

Event Description

During an ablation procedure to treat atrial fibrillation with a metriq tubing set, the tubing was occluded and could not be flushed.The tubing set was exchanged for another and the procedure was completed successfully.No patient complications were reported.

Event Description

During an ablation procedure to treat atrial fibrillation with a metriq tubing set, the tubing was occluded and could not be flushed.The tubing set was exchanged for another and the procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

Visual examination revealed no cuts, punctures, kinks or abrasions were found throughout the entire length of tubing.The fitting joints appeared normal.The irrigation tubing set was installed into a metriq pump.After approximately 30 seconds of purging all bubbles from the tubing at 60 ml/minute (purge flow rate), the pump was left running for 5 minute at 5 ml/minute (standby flow rate).No bubbles, occlusion, or communication warnings/alarms appeared on the pump's screen.The pump was increased to 30 ml/minute (ablation flow rate) for 5 minutes and measured approximately 150 ml of saline which is expected.No bubbles, occlusion, or communication warnings/alarms appeared on the pump's screen.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: METRIQ IRRIGATION TUBING SET
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10712496
• MDR Text Key: 212323075
• Report Number: 2134265-2020-14540
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729862208
• UDI-Public: 08714729862208
• Combination Product (y/n): N
• PMA/PMN Number: P150005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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: 03/31/2021
• Device Model Number: 86447
• Device Catalogue Number: 86447
• Device Lot Number: 0060231357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 01/19/2021
• Patient Sequence Number: 1