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	09/08/2023
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 during preparation for a pulmonary vein isolation procedure, an oi tubing set was selected for use, however, the device presented an issue.Once the tubing was loaded into the pump, the tubing sucked air in instead of pushing the saline out.Therefore, it was decided to replace the device, and the issue was resolved.The procedure was completed.No patient complications were reported.The device is expected to be returned for further analysis.
Event or Problem Description
It was reported that during preparation for a pulmonary vein isolation procedure, an oi tubing set was selected for use, however, the device presented an issue.Once the tubing was loaded into the pump, the tubing sucked air in instead of pushing the saline out.Therefore, it was decided to replace the device, and the issue was resolved.The procedure was completed.No patient complications were reported.The device was returned to boston scientific for laboratory analysis.
Additional Manufacturer Narrative
Oi tubing set was evaluated by boston scientific.Visual inspection did not note any defects.A flow test was performed; the tubing set was connected to a metriq pump and was purged at 60 ml/min.The pump was programmed to 30ml/min and the tubing was irrigated for 5 minutes without any errors or pump messages.No leaks were observed.The costumer attached a picture of the pouch, and it is possible to observe that the pouch information matches with the complaint information.Laboratory analysis was unable to confirm the reported clinical observation.Device was found within specifications.

• 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: timothy de groot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17866295
• Report Number: 2124215-2023-54651
• Device Sequence Number: 14893332
• Product Code: OAD
• UDI-Device Identifier: 08714729862208
• UDI-Public: 08714729862208
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/10/2024

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 Model Number: 86447
• Device Catalogue Number: 86447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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