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

Model Number	M0041170
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During setup, the tube was flushed but the air inside the tube was unable to be removed.During an ablation procedure to treat supraventricular tachycardia, a metriq irrigation tubing set was used.The tube was flushed during setup; however, the air was unable to be removed inside the tube.Another of the same device was used and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is (b)(6) center; reported here as the facility name exceeded character limit for designated field.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.

• 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 ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24105216
• Report Number: 2124215-2026-03336
• Device Sequence Number: 10328876
• Product Code: OAD
• UDI-Device Identifier: 08714729862208
• UDI-Public: (01)08714729862208(17)260505(10)60642802
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: 05/05/2026
• Device Model Number: M0041170
• Device Catalogue Number: M0041170
• Device Lot Number: 0060642802
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/17/2026
• Date Device Manufactured: 05/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown