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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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 an unusual substance or residue was noted to be attached on the device.A metriq irrigation tubing set was selected for use.During preparation, an unusual substance or residue was noted to be attached on the device.Another of the same device was used, and the procedure was completed successfully with no patient complications.The device was discarded and will not be returned for analysis.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported event of device foreign material present in device could not be confirmed.The device was discarded; therefore, a technical analysis could not be performed.The investigation findings did not lead to a clear conclusion about the cause of the reported event.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: the device was discarded; therefore, a technical analysis could not be performed.Labeling review: 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).Risk review: a review of the oi tubing set risk documentation was completed and confirmed that the event of device foreign material present in device.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific has assigned an investigation conclusion code of unable to exclude device problem.Without proper evaluation of the device, the investigation findings do not lead to a clear conclusion about the cause of the reported event.
Event or Problem Description
It was reported that an unusual substance or residue was noted to be attached on the device.A metriq irrigation tubing set was selected for use.During preparation, an unusual substance or residue was noted to be attached on the device.Another of the same device was used, and the procedure was completed successfully with no patient complications.The device was discarded 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: 24333095
• Report Number: 2124215-2026-08234
• Device Sequence Number: 21281858
• Product Code: OAD
• UDI-Device Identifier: 08714729862208
• UDI-Public: (01)08714729862208(17)260131(10)60619789
• 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,Followup
• Report Date (Section B): 03/18/2026

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: 01/31/2026
• Device Model Number: M0041170
• Device Catalogue Number: M0041170
• Device Lot Number: 0060619789
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 01/31/2025
• 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