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	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
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 the catheter exhibited insufficient flow or under infusion.During a pulmonary vein isolation procedure to treat third-degree atrial fibrillation in the left atrium, a metriq irrigation tubing set was selected for use.Although the irrigation tube was connected to the saline and priming was attempted, perfusion could not be performed.The tubing was reconnected several times, and the three-way stopcock was removed; however, perfusion still could not be achieved.No error message was displayed.The pump was not connected, and the saline bag was manually pressurized but could not be refluxed.The issue occurred during priming outside the patient.The device was replaced with another of the same model, which resolved the issue, and the procedure was completed successfully.There were no patient complications.The device was discarded by the facility 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 ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22663454
• Report Number: 2124215-2025-50032
• Device Sequence Number: 17072816
• Product Code: OAD
• UDI-Device Identifier: 08714729862208
• UDI-Public: (01)08714729862208(17)251014(10)60595946
• 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): 07/30/2025

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: 10/14/2025
• Device Model Number: 86447
• Device Catalogue Number: 86447
• Device Lot Number: 0060595946
• 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: 07/08/2025
• Initial Report FDA Received Date: 07/30/2025
• Date Device Manufactured: 10/14/2024
• 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