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	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the tubing set had an insufficient flow when flushing.During an ablation procedure to treat atrial fibrillation (af), a metriq irrigation tubing set was selected for use.When flushing, the water did not flow as expected through the tubing; it was slower than expected.Believing this posed a risk for air to appear the tubing was replaced.The procedure was completed successfully with no patient complications.The product is expected to be returned for analysis.
Event or Problem Description
It was reported that the tubing set had an insufficient flow when flushing.During an ablation procedure to treat atrial fibrillation (af), a metriq irrigation tubing set was selected for use.When flushing, the water did not flow as expected through the tubing; it was slower than expected.Believing this posed a risk for air to appear the tubing was replaced.The procedure was completed successfully with no patient complications.The product is expected to be returned for analysis.It was further reported that no error messages displayed.When flushing of the tube set was performed, the water was difficult to supply.They were unable to flush the water before using the pump, so they did not use the pump.After they changed the tubing, the irrigation flow rate was 30ml/min and irrigation had not been interrupted or stopped.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.The device did not have visual defects.The device was connected to a metriq pump and was purged at 60 ml/min.It flowed freely.The pump was programmed to 30ml/min and the device was irrigated for 5 minutes without any errors or pump messages.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20748270
• Report Number: 2124215-2024-73463
• Device Sequence Number: 8287365
• Product Code: OAD
• UDI-Device Identifier: 08714729862208
• UDI-Public: 08714729862208
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 04/09/2025
• Device Model Number: 86447
• Device Catalogue Number: 86447
• Device Lot Number: 0060553153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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