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

Model Number	86447
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that small air bubbles were observed in the line, but they were not detected by the metriq device.During an ablation procedure to treat atrial fibrillation (afib), a metriq irrigation tubing set was selected for use.Small air bubbles were observed in the line, but they were not detected by the metriq device.The line was flushed and tapped, but the bubbles were not removed.The tubing was then replaced, but the issue was not resolved.Subsequently, a pressure bag was used, and the procedure was completed successfully with no patient complications.The product has been disposed of and will not be returned for analysis.

• Brand Name: METRIQ IRRIGATION TUBING SET
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: mary crawford crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21928715
• Report Number: 2124215-2025-25909
• Device Sequence Number: 9022272
• Product Code: OAD
• UDI-Device Identifier: 08714729862208
• UDI-Public: (01)08714729862208(17)250717(10)60575901
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2025
• Device Model Number: 86447
• Device Catalogue Number: 86447
• Device Lot Number: 0060575901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/29/2025
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown